Headache & Migraine

Key clinical point: Administration of monthly or quarterly fremanezumab reduced acute medication use and alleviated migraine-associated symptoms in patients with episodic migraine (EM).

Major findings: Fremanezumab, administered monthly vs placebo significantly reduced the acute medication use for headaches (–2.98 vs –0.01; P < .001) and number of days with nausea or vomiting (–1.59 vs –0.66; P = .023) in the first month after initial dosage, with continued benefits till months 2 and 3. Fremanezumab, administered quarterly, also yielded promising outcomes.

Study details: Findings are from an exploratory endpoint analysis of a phase 2b/3 randomized trial including patients with EM who were randomly assigned to receive either monthly fremanezumab (n =  121), quarterly fremanezumab (n =  119), or placebo (n =  117) in monthly intervals.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Five authors declared being full-time employees of Otsuka Pharmaceutical Co., Ltd. Other authors declared having other ties with various sources, including Otsuka Pharmaceutical Co., Ltd.

Source: Tatsumoto M, Ishida M, Iba K, et al. Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14810 Source

Key clinical point: Administration of monthly or quarterly fremanezumab reduced acute medication use and alleviated migraine-associated symptoms in patients with episodic migraine (EM).

Major findings: Fremanezumab, administered monthly vs placebo significantly reduced the acute medication use for headaches (–2.98 vs –0.01; P < .001) and number of days with nausea or vomiting (–1.59 vs –0.66; P = .023) in the first month after initial dosage, with continued benefits till months 2 and 3. Fremanezumab, administered quarterly, also yielded promising outcomes.

Study details: Findings are from an exploratory endpoint analysis of a phase 2b/3 randomized trial including patients with EM who were randomly assigned to receive either monthly fremanezumab (n =  121), quarterly fremanezumab (n =  119), or placebo (n =  117) in monthly intervals.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Five authors declared being full-time employees of Otsuka Pharmaceutical Co., Ltd. Other authors declared having other ties with various sources, including Otsuka Pharmaceutical Co., Ltd.

Source: Tatsumoto M, Ishida M, Iba K, et al. Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14810 Source

Key clinical point: Administration of monthly or quarterly fremanezumab reduced acute medication use and alleviated migraine-associated symptoms in patients with episodic migraine (EM).

Major findings: Fremanezumab, administered monthly vs placebo significantly reduced the acute medication use for headaches (–2.98 vs –0.01; P < .001) and number of days with nausea or vomiting (–1.59 vs –0.66; P = .023) in the first month after initial dosage, with continued benefits till months 2 and 3. Fremanezumab, administered quarterly, also yielded promising outcomes.

Study details: Findings are from an exploratory endpoint analysis of a phase 2b/3 randomized trial including patients with EM who were randomly assigned to receive either monthly fremanezumab (n =  121), quarterly fremanezumab (n =  119), or placebo (n =  117) in monthly intervals.

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd. Five authors declared being full-time employees of Otsuka Pharmaceutical Co., Ltd. Other authors declared having other ties with various sources, including Otsuka Pharmaceutical Co., Ltd.

Source: Tatsumoto M, Ishida M, Iba K, et al. Effects of fremanezumab on migraine-associated symptoms and medication use in Japanese and Korean patients with episodic migraine: Exploratory endpoint analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14810 Source

Key clinical point: Eicosapentaenoic acid (EPA), used with standard prophylactic pharmacotherapy, significantly reduced migraine headache days (MHD) and migraine attacks in patients with chronic migraine (CM).

Major findings: The score relating to headache impact was significantly lower in the EPA vs placebo group at weeks 4 (P = .017) and 8 (P = .042). At 8 weeks, EPA treatment led to a greater reduction in mean MHD (−9.76 vs −4.60; P < .001) and mean number of attacks per month (3 vs 4; P = .012) than placebo. In the EPA group, only three patients experienced nausea and gastrointestinal upset.

Study details: This randomized controlled trial included 60 adult patients with CM who received 1000 mg EPA or placebo twice daily for 8 weeks and continued their first-line preventive pharmacotherapy throughout the trial.

Disclosure: The study was supported by the research committee of Shahid Beheshti University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Mohammadnezhad G, Assarzadegan F, Koosha M, Esmaily H. Eicosapentaenoic acid versus placebo as adjunctive therapy in chronic migraine: A randomized controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14808  Source

Key clinical point: Eicosapentaenoic acid (EPA), used with standard prophylactic pharmacotherapy, significantly reduced migraine headache days (MHD) and migraine attacks in patients with chronic migraine (CM).

Major findings: The score relating to headache impact was significantly lower in the EPA vs placebo group at weeks 4 (P = .017) and 8 (P = .042). At 8 weeks, EPA treatment led to a greater reduction in mean MHD (−9.76 vs −4.60; P < .001) and mean number of attacks per month (3 vs 4; P = .012) than placebo. In the EPA group, only three patients experienced nausea and gastrointestinal upset.

Study details: This randomized controlled trial included 60 adult patients with CM who received 1000 mg EPA or placebo twice daily for 8 weeks and continued their first-line preventive pharmacotherapy throughout the trial.

Disclosure: The study was supported by the research committee of Shahid Beheshti University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Mohammadnezhad G, Assarzadegan F, Koosha M, Esmaily H. Eicosapentaenoic acid versus placebo as adjunctive therapy in chronic migraine: A randomized controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14808  Source

Key clinical point: Eicosapentaenoic acid (EPA), used with standard prophylactic pharmacotherapy, significantly reduced migraine headache days (MHD) and migraine attacks in patients with chronic migraine (CM).

Major findings: The score relating to headache impact was significantly lower in the EPA vs placebo group at weeks 4 (P = .017) and 8 (P = .042). At 8 weeks, EPA treatment led to a greater reduction in mean MHD (−9.76 vs −4.60; P < .001) and mean number of attacks per month (3 vs 4; P = .012) than placebo. In the EPA group, only three patients experienced nausea and gastrointestinal upset.

Study details: This randomized controlled trial included 60 adult patients with CM who received 1000 mg EPA or placebo twice daily for 8 weeks and continued their first-line preventive pharmacotherapy throughout the trial.

Disclosure: The study was supported by the research committee of Shahid Beheshti University of Medical Sciences, Iran. The authors declared no conflicts of interest.

Source: Mohammadnezhad G, Assarzadegan F, Koosha M, Esmaily H. Eicosapentaenoic acid versus placebo as adjunctive therapy in chronic migraine: A randomized controlled trial. Headache. 2024 (Sept 2). doi: 10.1111/head.14808  Source

Key clinical point: Zavegepant nasal spray, administered as needed for up to eight doses per month, demonstrated long-term safety in the acute treatment of migraine over 1 year.

Major finding: The most common adverse events (AE), reported in ≥5% patients receiving zavegepant, were dysgeusia, nasal discomfort, COVID-19, nausea, nasal congestion, throat irritation, and back pain. In the 1-year period, only 6.8% patients discontinued treatment due to AE; dysgeusia was the most common cause, accounting for 1.5% of discontinuations. No deaths were reported.

Study details: This phase 2/3, open-label safety study included 603 adults with moderate to severe migraine who had a history of 2 to 8 moderate to severe attacks per month and were treated with intranasal 10 mg zavegepant daily for 1 year.

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of or holding stocks of or stock options in Biohaven Pharmaceuticals. Some others declared having ties with various sources, including Biohaven Pharmaceuticals.

Source: Mullin K, Croop R, Mosher L, et al. Long-term safety of zavegepant nasal spray for acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 (Aug 30). doi: 10.1177/033310242412594 Source

Key clinical point: Zavegepant nasal spray, administered as needed for up to eight doses per month, demonstrated long-term safety in the acute treatment of migraine over 1 year.

Major finding: The most common adverse events (AE), reported in ≥5% patients receiving zavegepant, were dysgeusia, nasal discomfort, COVID-19, nausea, nasal congestion, throat irritation, and back pain. In the 1-year period, only 6.8% patients discontinued treatment due to AE; dysgeusia was the most common cause, accounting for 1.5% of discontinuations. No deaths were reported.

Study details: This phase 2/3, open-label safety study included 603 adults with moderate to severe migraine who had a history of 2 to 8 moderate to severe attacks per month and were treated with intranasal 10 mg zavegepant daily for 1 year.

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of or holding stocks of or stock options in Biohaven Pharmaceuticals. Some others declared having ties with various sources, including Biohaven Pharmaceuticals.

Source: Mullin K, Croop R, Mosher L, et al. Long-term safety of zavegepant nasal spray for acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 (Aug 30). doi: 10.1177/033310242412594 Source

Key clinical point: Zavegepant nasal spray, administered as needed for up to eight doses per month, demonstrated long-term safety in the acute treatment of migraine over 1 year.

Major finding: The most common adverse events (AE), reported in ≥5% patients receiving zavegepant, were dysgeusia, nasal discomfort, COVID-19, nausea, nasal congestion, throat irritation, and back pain. In the 1-year period, only 6.8% patients discontinued treatment due to AE; dysgeusia was the most common cause, accounting for 1.5% of discontinuations. No deaths were reported.

Study details: This phase 2/3, open-label safety study included 603 adults with moderate to severe migraine who had a history of 2 to 8 moderate to severe attacks per month and were treated with intranasal 10 mg zavegepant daily for 1 year.

Disclosures: This study was funded by Biohaven Pharmaceuticals. Some authors declared being employees of or holding stocks of or stock options in Biohaven Pharmaceuticals. Some others declared having ties with various sources, including Biohaven Pharmaceuticals.

Source: Mullin K, Croop R, Mosher L, et al. Long-term safety of zavegepant nasal spray for acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 (Aug 30). doi: 10.1177/033310242412594 Source

Key clinical point: Women with either migraine or gestational diabetes mellitus (GDM) faced an increased long-term risk for developing major adverse cardiovascular and cerebrovascular events (MACCE) at a premature age (≤60 years), with the risk being significantly higher among those with both conditions.

Major findings: Women with migraine or GDM had a significantly higher 20-year risk for premature MACCE than women without these conditions (adjusted hazard ratio [aHR] 1.65; 95% CI 1.49-1.82 for migraine and aHR 1.64; 95% CI 1.37-1.96 for GDM). The risk was highest among women with both migraine and GDM (aHR 2.35; 95% CI 1.03-5.36).

Study details: This population-based longitudinal cohort study included 1,390,451 women, of which 56,811 had migraine, 24,700 had GDM, 1484 had both migraine and GDM, and 1,307,456 women had neither migraine nor GDM.

Disclosure: The study was funded by Aarhus University. The authors declared no conflicts of interest.

Source: Fuglsang CH, Pedersen L, Schmidt M, et al. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 (Aug 28). doi: 10.1111/head.14821 Source

Key clinical point: Women with either migraine or gestational diabetes mellitus (GDM) faced an increased long-term risk for developing major adverse cardiovascular and cerebrovascular events (MACCE) at a premature age (≤60 years), with the risk being significantly higher among those with both conditions.

Major findings: Women with migraine or GDM had a significantly higher 20-year risk for premature MACCE than women without these conditions (adjusted hazard ratio [aHR] 1.65; 95% CI 1.49-1.82 for migraine and aHR 1.64; 95% CI 1.37-1.96 for GDM). The risk was highest among women with both migraine and GDM (aHR 2.35; 95% CI 1.03-5.36).

Study details: This population-based longitudinal cohort study included 1,390,451 women, of which 56,811 had migraine, 24,700 had GDM, 1484 had both migraine and GDM, and 1,307,456 women had neither migraine nor GDM.

Disclosure: The study was funded by Aarhus University. The authors declared no conflicts of interest.

Source: Fuglsang CH, Pedersen L, Schmidt M, et al. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 (Aug 28). doi: 10.1111/head.14821 Source

Key clinical point: Women with either migraine or gestational diabetes mellitus (GDM) faced an increased long-term risk for developing major adverse cardiovascular and cerebrovascular events (MACCE) at a premature age (≤60 years), with the risk being significantly higher among those with both conditions.

Major findings: Women with migraine or GDM had a significantly higher 20-year risk for premature MACCE than women without these conditions (adjusted hazard ratio [aHR] 1.65; 95% CI 1.49-1.82 for migraine and aHR 1.64; 95% CI 1.37-1.96 for GDM). The risk was highest among women with both migraine and GDM (aHR 2.35; 95% CI 1.03-5.36).

Study details: This population-based longitudinal cohort study included 1,390,451 women, of which 56,811 had migraine, 24,700 had GDM, 1484 had both migraine and GDM, and 1,307,456 women had neither migraine nor GDM.

Disclosure: The study was funded by Aarhus University. The authors declared no conflicts of interest.

Source: Fuglsang CH, Pedersen L, Schmidt M, et al. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 (Aug 28). doi: 10.1111/head.14821 Source

Key clinical point: Patients with migraine experienced considerable neck pain–related disability, with the effect being more prominent among patients with chronic vs episodic migraine.

Major findings: Patients with migraine reported a mean Neck Disability Index (NDI) score of 16.2, indicative of moderate disability. The NDI scores were 12.1 points higher among patients with migraine vs control individuals without headache (P < .001) and 5.5 points higher among patients with chronic vs episodic migraine (P < .001).

Study details: Findings are from a meta-analysis of 33 observational studies including patients with migraine, patients with tension-type headache, and healthy individuals without headache.

Disclosure: The study did not receive any funding. Four authors declared receiving personal fees or honoraria for consultation from or having other ties with various sources; others declared no conflicts of interest.

Source: Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024 (Aug 28). doi: 10.1177/033310242412742 Source

Key clinical point: Patients with migraine experienced considerable neck pain–related disability, with the effect being more prominent among patients with chronic vs episodic migraine.

Major findings: Patients with migraine reported a mean Neck Disability Index (NDI) score of 16.2, indicative of moderate disability. The NDI scores were 12.1 points higher among patients with migraine vs control individuals without headache (P < .001) and 5.5 points higher among patients with chronic vs episodic migraine (P < .001).

Study details: Findings are from a meta-analysis of 33 observational studies including patients with migraine, patients with tension-type headache, and healthy individuals without headache.

Disclosure: The study did not receive any funding. Four authors declared receiving personal fees or honoraria for consultation from or having other ties with various sources; others declared no conflicts of interest.

Source: Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024 (Aug 28). doi: 10.1177/033310242412742 Source

Key clinical point: Patients with migraine experienced considerable neck pain–related disability, with the effect being more prominent among patients with chronic vs episodic migraine.

Major findings: Patients with migraine reported a mean Neck Disability Index (NDI) score of 16.2, indicative of moderate disability. The NDI scores were 12.1 points higher among patients with migraine vs control individuals without headache (P < .001) and 5.5 points higher among patients with chronic vs episodic migraine (P < .001).

Study details: Findings are from a meta-analysis of 33 observational studies including patients with migraine, patients with tension-type headache, and healthy individuals without headache.

Disclosure: The study did not receive any funding. Four authors declared receiving personal fees or honoraria for consultation from or having other ties with various sources; others declared no conflicts of interest.

Source: Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024 (Aug 28). doi: 10.1177/033310242412742 Source

Key clinical point: When administered during the prodrome, ubrogepant was more effective than placebo in improving normal functioning, reducing activity limitations, and increasing treatment satisfaction in patients with acute migraine.

Major findings: A significantly higher proportion of patients were able to function normally as early as 2 hours after receiving ubrogepant vs placebo (odds ratio [OR] 1.76; P = .0001), with the effects being sustained through 24 hours. The patients also experienced reduced activity limitations (OR 2.07; P < .0001) and greater treatment satisfaction (OR 2.32; P < .0001) at 24 hours after receiving ubrogepant vs placebo.

Study details: This PRODROME trial included 477 adult patients with acute migraine who were randomly assigned to receive either placebo followed by 100 mg ubrogepant for the first and second prodrome events, respectively, or vice versa.

Disclosure: The study was funded by AbbVie. Seven authors reported being employees of AbbVie and may hold stock in the company. Other authors declared having other ties with various sources, including AbbVie.

Source: Lipton RB, Harriott AM, Ma JY, et al. Effect of ubrogepant on patient-reported outcomes when administered during the migraine prodrome: Results from the randomized PRODROME trial. Neurology. 2024;103(6):e209745 (Aug 28). doi: 10.1212/WNL.00000000002097 Source

Key clinical point: When administered during the prodrome, ubrogepant was more effective than placebo in improving normal functioning, reducing activity limitations, and increasing treatment satisfaction in patients with acute migraine.

Major findings: A significantly higher proportion of patients were able to function normally as early as 2 hours after receiving ubrogepant vs placebo (odds ratio [OR] 1.76; P = .0001), with the effects being sustained through 24 hours. The patients also experienced reduced activity limitations (OR 2.07; P < .0001) and greater treatment satisfaction (OR 2.32; P < .0001) at 24 hours after receiving ubrogepant vs placebo.

Study details: This PRODROME trial included 477 adult patients with acute migraine who were randomly assigned to receive either placebo followed by 100 mg ubrogepant for the first and second prodrome events, respectively, or vice versa.

Disclosure: The study was funded by AbbVie. Seven authors reported being employees of AbbVie and may hold stock in the company. Other authors declared having other ties with various sources, including AbbVie.

Source: Lipton RB, Harriott AM, Ma JY, et al. Effect of ubrogepant on patient-reported outcomes when administered during the migraine prodrome: Results from the randomized PRODROME trial. Neurology. 2024;103(6):e209745 (Aug 28). doi: 10.1212/WNL.00000000002097 Source

Key clinical point: When administered during the prodrome, ubrogepant was more effective than placebo in improving normal functioning, reducing activity limitations, and increasing treatment satisfaction in patients with acute migraine.

Major findings: A significantly higher proportion of patients were able to function normally as early as 2 hours after receiving ubrogepant vs placebo (odds ratio [OR] 1.76; P = .0001), with the effects being sustained through 24 hours. The patients also experienced reduced activity limitations (OR 2.07; P < .0001) and greater treatment satisfaction (OR 2.32; P < .0001) at 24 hours after receiving ubrogepant vs placebo.

Study details: This PRODROME trial included 477 adult patients with acute migraine who were randomly assigned to receive either placebo followed by 100 mg ubrogepant for the first and second prodrome events, respectively, or vice versa.

Disclosure: The study was funded by AbbVie. Seven authors reported being employees of AbbVie and may hold stock in the company. Other authors declared having other ties with various sources, including AbbVie.

Source: Lipton RB, Harriott AM, Ma JY, et al. Effect of ubrogepant on patient-reported outcomes when administered during the migraine prodrome: Results from the randomized PRODROME trial. Neurology. 2024;103(6):e209745 (Aug 28). doi: 10.1212/WNL.00000000002097 Source

Key clinical point: Middle-aged and older women showed no significant association between migraine, and the risk for Parkinson disease (PD), irrespective of migraine subtypes and frequency.

Major findings: Compared to women with without migraine, those with migraine did not show a risk of PD (adjusted hazard ratio [aHR] 1.07; 95% CI 0.88-1.29) irrespective of the presence of aura. No risk was seen even if patients had monthly migraine frequency (aHR 1.09; 95% CI 0.64-1.87), or a weekly or greater migraine frequency (aHR 1.10; 95% CI 0.44-2.75).

Study details: This study involved 39,312 women (age > 45 years) of whom 7321 had migraines, including 2153 with a history of migraine and 5168 with migraine with or without aura. None had a history of PD.

Disclosure: This study was supported by grants from the US National Cancer Institute and the US National Heart, Lung, and Blood Institute. Two authors declared receiving research grants or personal compensation from various sources.

Source: Schulz RS, Glatz T, Buring Jeet al. Migraine and risk of Parkinson disease in women: A cohort study. Neurology. 2024;103(6):e209747 (Aug 21). doi: 10.1212/WNL.0000000000209747 Source

Key clinical point: Middle-aged and older women showed no significant association between migraine, and the risk for Parkinson disease (PD), irrespective of migraine subtypes and frequency.

Major findings: Compared to women with without migraine, those with migraine did not show a risk of PD (adjusted hazard ratio [aHR] 1.07; 95% CI 0.88-1.29) irrespective of the presence of aura. No risk was seen even if patients had monthly migraine frequency (aHR 1.09; 95% CI 0.64-1.87), or a weekly or greater migraine frequency (aHR 1.10; 95% CI 0.44-2.75).

Study details: This study involved 39,312 women (age > 45 years) of whom 7321 had migraines, including 2153 with a history of migraine and 5168 with migraine with or without aura. None had a history of PD.

Disclosure: This study was supported by grants from the US National Cancer Institute and the US National Heart, Lung, and Blood Institute. Two authors declared receiving research grants or personal compensation from various sources.

Source: Schulz RS, Glatz T, Buring Jeet al. Migraine and risk of Parkinson disease in women: A cohort study. Neurology. 2024;103(6):e209747 (Aug 21). doi: 10.1212/WNL.0000000000209747 Source

Key clinical point: Middle-aged and older women showed no significant association between migraine, and the risk for Parkinson disease (PD), irrespective of migraine subtypes and frequency.

Major findings: Compared to women with without migraine, those with migraine did not show a risk of PD (adjusted hazard ratio [aHR] 1.07; 95% CI 0.88-1.29) irrespective of the presence of aura. No risk was seen even if patients had monthly migraine frequency (aHR 1.09; 95% CI 0.64-1.87), or a weekly or greater migraine frequency (aHR 1.10; 95% CI 0.44-2.75).

Study details: This study involved 39,312 women (age > 45 years) of whom 7321 had migraines, including 2153 with a history of migraine and 5168 with migraine with or without aura. None had a history of PD.

Disclosure: This study was supported by grants from the US National Cancer Institute and the US National Heart, Lung, and Blood Institute. Two authors declared receiving research grants or personal compensation from various sources.

Source: Schulz RS, Glatz T, Buring Jeet al. Migraine and risk of Parkinson disease in women: A cohort study. Neurology. 2024;103(6):e209747 (Aug 21). doi: 10.1212/WNL.0000000000209747 Source

Key clinical point: A single infusion of Lu AG09222, a humanized monoclonal antibody targeting the pituitary adenylate cyclase-activating polypeptide, was more effective than placebo in reducing migraine frequency over 4 weeks in adults with episodic or chronic migraine.

Major findings: Through week 4, a single infusion of 750 mg Lu AG09222 vs placebo led to a significantly greater reduction in monthly migraine days (−6.2 vs −4.2 days; difference −2 days; P = .02). Most adverse events were mild, with COVID-19, nasopharyngitis, and fatigue being more prevalent in those receiving 750 mg Lu AG09222 vs placebo.

Study details: This phase 2 trial included 237 adults with migraine who did not respond to two to four previous treatments and were assigned to receive either Lu AG09222 (750 mg or 100 mg) or placebo for 4 weeks.

Disclosure: The study was supported by H. Lundbeck A/S. Three authors declared being employees of H. Lundbeck A/S, of whom one held stock options. One author reported receiving consulting, speaker, and advisory board fees from various sources, including H. Lundbeck A/S.

Source: Ashina M, Phul R, Khodaie M, et al. A monoclonal antibody to PACAP for migraine prevention. N Engl J Med. 2024;391(9):800-809 (Sept 4). doi: 10.1056/NEJMoa2314577 Source

Key clinical point: A single infusion of Lu AG09222, a humanized monoclonal antibody targeting the pituitary adenylate cyclase-activating polypeptide, was more effective than placebo in reducing migraine frequency over 4 weeks in adults with episodic or chronic migraine.

Major findings: Through week 4, a single infusion of 750 mg Lu AG09222 vs placebo led to a significantly greater reduction in monthly migraine days (−6.2 vs −4.2 days; difference −2 days; P = .02). Most adverse events were mild, with COVID-19, nasopharyngitis, and fatigue being more prevalent in those receiving 750 mg Lu AG09222 vs placebo.

Study details: This phase 2 trial included 237 adults with migraine who did not respond to two to four previous treatments and were assigned to receive either Lu AG09222 (750 mg or 100 mg) or placebo for 4 weeks.

Disclosure: The study was supported by H. Lundbeck A/S. Three authors declared being employees of H. Lundbeck A/S, of whom one held stock options. One author reported receiving consulting, speaker, and advisory board fees from various sources, including H. Lundbeck A/S.

Source: Ashina M, Phul R, Khodaie M, et al. A monoclonal antibody to PACAP for migraine prevention. N Engl J Med. 2024;391(9):800-809 (Sept 4). doi: 10.1056/NEJMoa2314577 Source

Key clinical point: A single infusion of Lu AG09222, a humanized monoclonal antibody targeting the pituitary adenylate cyclase-activating polypeptide, was more effective than placebo in reducing migraine frequency over 4 weeks in adults with episodic or chronic migraine.

Major findings: Through week 4, a single infusion of 750 mg Lu AG09222 vs placebo led to a significantly greater reduction in monthly migraine days (−6.2 vs −4.2 days; difference −2 days; P = .02). Most adverse events were mild, with COVID-19, nasopharyngitis, and fatigue being more prevalent in those receiving 750 mg Lu AG09222 vs placebo.

Study details: This phase 2 trial included 237 adults with migraine who did not respond to two to four previous treatments and were assigned to receive either Lu AG09222 (750 mg or 100 mg) or placebo for 4 weeks.

Disclosure: The study was supported by H. Lundbeck A/S. Three authors declared being employees of H. Lundbeck A/S, of whom one held stock options. One author reported receiving consulting, speaker, and advisory board fees from various sources, including H. Lundbeck A/S.

Source: Ashina M, Phul R, Khodaie M, et al. A monoclonal antibody to PACAP for migraine prevention. N Engl J Med. 2024;391(9):800-809 (Sept 4). doi: 10.1056/NEJMoa2314577 Source

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A history of migraine is not associated with an elevated risk for Parkinson’s disease (PD) in women, regardless of headache frequency or migraine subtype, a new study suggests.

METHODOLOGY:

• Researchers analyzed data on 39,312 women health professionals aged ≥ 45 years and having no history of PD who enrolled in the Women’s Health Study between 1992 and 1995 and were followed until 2021.
• At baseline, 7321 women (18.6%) had migraine.
• The mean follow-up duration was 22 years.
• The primary outcome was a self-reported, physician-confirmed diagnosis of PD.

TAKEAWAY:

• During the study period, 685 women self-reported a diagnosis of PD.
• Of these, 18.7% of reported cases were in women with any migraine and 81.3% in women without migraine.
• No significant association was found between PD risk and a history of migraine, migraine subtypes (with or without aura), or migraine frequency.
• Migraine was not associated with a higher risk for PD than that of nonmigraine headaches.

IN PRACTICE:

“These results are reassuring for women who have migraine, which itself causes many burdens, that they don’t have to worry about an increased risk of Parkinson’s disease in the future,” study author Tobias Kurth, Charité - Universitätsmedizin Berlin, Germany, said in a press release.

SOURCE:

The study was led by Ricarda S. Schulz, MSc, Charité - Universitätsmedizin Berlin. It was published online in Neurology.

LIMITATIONS:

The study’s findings may not be generalizable to other populations, such as men and non-White individuals. The self-reported data on migraine and PD may be subject to inaccuracies. PD is often not diagnosed until symptoms have reached an advanced stage, potentially leading to cases being underreported. Changes in the status and frequency of migraine over the study period were not accounted for, which may have affected the results.

DISCLOSURES:

The authors did not disclose any specific funding for this work. The Women’s Health Study was supported by the National Cancer Institute and National Heart, Lung, and Blood Institute. Two authors reported having financial ties outside this work. Full disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Earlier in 2024 the American Headache Society issued a position statement that CGRP (calcitonin gene-related peptide) agents are a first-line option for migraine prevention.

No Shinola, Sherlock.

Any of us working frontline neurology have figured that out, including me. And I was, honestly, pretty skeptical of them when they hit the pharmacy shelves. But these days, to quote The Monkees (and Neil Diamond), “I’m a Believer.”

Unfortunately, things don’t quite work out that way. Just because a drug is clearly successful doesn’t make it practical to use first line. Most insurances won’t even let family doctors prescribe them, so they have to send patients to a neurologist (which I’m not complaining about).

Then me and my neuro-brethren have to jump through hoops because of their cost. One month of any of these drugs costs the same as a few years (or more) of generic Topamax, Nortriptyline, Nadolol, etc. Granted, I shouldn’t complain about that, either. If everyone with migraines was getting them it would drive up insurance premiums across the board — including mine.

So, after patients have tried and failed at least two to four other options (depending on their plan) I can usually get a CGRP covered. This involves filling out some forms online and submitting them ... then waiting.

Even if the drug is approved, and successful, that’s still not the end of the story. Depending on the plan I have to get them reauthorized anywhere from every 3 to 12 months. There’s also the chance that in December I’ll get a letter saying the drug won’t be covered starting January, and to try one of the recommended alternatives, like generic Topamax, Nortriptyline, Nadolol, etc. Wash, rinse, repeat.

Having celebrities like Lady Gaga pushing them doesn’t help. The commercials never mention that getting the medication isn’t as easy as “ask your doctor.” Nor does it point out that Lady Gaga won’t have an issue with a CGRP agent’s price tag of $800-$1000 per month, while most of her fans need that money for rent and groceries.

The guidelines, in essence, are useful, but only apply to a perfect world where drug cost doesn’t matter. We aren’t in one. I’m not knocking the pharmaceutical companies — research and development take A LOT of money, and every drug that comes to market has to pay not only for itself, but for several others that failed. Innovation isn’t cheap.

That doesn’t make it any easier to explain to patients, who see ads, or news blurbs on Facebook, or whatever. I just wish the advertisements would have more transparency about how the pricing works.

After all, regardless of how good an automobile may be, don’t car ads show an MSRP?

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Earlier in 2024 the American Headache Society issued a position statement that CGRP (calcitonin gene-related peptide) agents are a first-line option for migraine prevention.

No Shinola, Sherlock.

Any of us working frontline neurology have figured that out, including me. And I was, honestly, pretty skeptical of them when they hit the pharmacy shelves. But these days, to quote The Monkees (and Neil Diamond), “I’m a Believer.”

Unfortunately, things don’t quite work out that way. Just because a drug is clearly successful doesn’t make it practical to use first line. Most insurances won’t even let family doctors prescribe them, so they have to send patients to a neurologist (which I’m not complaining about).

Then me and my neuro-brethren have to jump through hoops because of their cost. One month of any of these drugs costs the same as a few years (or more) of generic Topamax, Nortriptyline, Nadolol, etc. Granted, I shouldn’t complain about that, either. If everyone with migraines was getting them it would drive up insurance premiums across the board — including mine.

So, after patients have tried and failed at least two to four other options (depending on their plan) I can usually get a CGRP covered. This involves filling out some forms online and submitting them ... then waiting.

Even if the drug is approved, and successful, that’s still not the end of the story. Depending on the plan I have to get them reauthorized anywhere from every 3 to 12 months. There’s also the chance that in December I’ll get a letter saying the drug won’t be covered starting January, and to try one of the recommended alternatives, like generic Topamax, Nortriptyline, Nadolol, etc. Wash, rinse, repeat.

Having celebrities like Lady Gaga pushing them doesn’t help. The commercials never mention that getting the medication isn’t as easy as “ask your doctor.” Nor does it point out that Lady Gaga won’t have an issue with a CGRP agent’s price tag of $800-$1000 per month, while most of her fans need that money for rent and groceries.

The guidelines, in essence, are useful, but only apply to a perfect world where drug cost doesn’t matter. We aren’t in one. I’m not knocking the pharmaceutical companies — research and development take A LOT of money, and every drug that comes to market has to pay not only for itself, but for several others that failed. Innovation isn’t cheap.

That doesn’t make it any easier to explain to patients, who see ads, or news blurbs on Facebook, or whatever. I just wish the advertisements would have more transparency about how the pricing works.

After all, regardless of how good an automobile may be, don’t car ads show an MSRP?

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Earlier in 2024 the American Headache Society issued a position statement that CGRP (calcitonin gene-related peptide) agents are a first-line option for migraine prevention.

No Shinola, Sherlock.

Any of us working frontline neurology have figured that out, including me. And I was, honestly, pretty skeptical of them when they hit the pharmacy shelves. But these days, to quote The Monkees (and Neil Diamond), “I’m a Believer.”

Unfortunately, things don’t quite work out that way. Just because a drug is clearly successful doesn’t make it practical to use first line. Most insurances won’t even let family doctors prescribe them, so they have to send patients to a neurologist (which I’m not complaining about).

Then me and my neuro-brethren have to jump through hoops because of their cost. One month of any of these drugs costs the same as a few years (or more) of generic Topamax, Nortriptyline, Nadolol, etc. Granted, I shouldn’t complain about that, either. If everyone with migraines was getting them it would drive up insurance premiums across the board — including mine.

So, after patients have tried and failed at least two to four other options (depending on their plan) I can usually get a CGRP covered. This involves filling out some forms online and submitting them ... then waiting.

Even if the drug is approved, and successful, that’s still not the end of the story. Depending on the plan I have to get them reauthorized anywhere from every 3 to 12 months. There’s also the chance that in December I’ll get a letter saying the drug won’t be covered starting January, and to try one of the recommended alternatives, like generic Topamax, Nortriptyline, Nadolol, etc. Wash, rinse, repeat.

Having celebrities like Lady Gaga pushing them doesn’t help. The commercials never mention that getting the medication isn’t as easy as “ask your doctor.” Nor does it point out that Lady Gaga won’t have an issue with a CGRP agent’s price tag of $800-$1000 per month, while most of her fans need that money for rent and groceries.

The guidelines, in essence, are useful, but only apply to a perfect world where drug cost doesn’t matter. We aren’t in one. I’m not knocking the pharmaceutical companies — research and development take A LOT of money, and every drug that comes to market has to pay not only for itself, but for several others that failed. Innovation isn’t cheap.

That doesn’t make it any easier to explain to patients, who see ads, or news blurbs on Facebook, or whatever. I just wish the advertisements would have more transparency about how the pricing works.

After all, regardless of how good an automobile may be, don’t car ads show an MSRP?

Dr. Block has a solo neurology practice in Scottsdale, Arizona.