Headache & Migraine

Key clinical point: Adenosine vs placebo infusion increased headaches and short-lasting vasodilation without a significant induction of migraine attacks in patients with migraine without aura.

Major finding: The incidence of migraine attacks was not significantly different after adenosine vs placebo infusion (39% vs 17%; P = .29); however, a higher proportion of patients receiving adenosine vs placebo reported headache (78% vs 33%; P < .01). Adenosine vs placebo increased heart rate (area under the curve [AUC]_{T0-120 min}, P < .001), facial skin blood flow (AUC_{T0-120 min}, P < .05), and left superficial temporal artery diameter (AUC_{T0-20 min}, P = .01), but decreased middle cerebral artery blood flow velocity (AUC_{T0-20 min}, P < .001).

Study details: This randomized controlled trial included 18 patients with migraine without aura who received adenosine or placebo infusion over 20 minutes on two study days separated by a 1 week washout period.

Disclosures: This study received support from the Lundbeck Foundation. M Ashina reported receiving consulting fees, honoraria for lectures and presentations, and royalties from various sources, including Lundbeck.

Source: Thuraiaiyah J et al. Adenosine causes short-lasting vasodilation and headache, but not migraine attacks in migraine patients: A randomized clinical trial. Pain. 2022 (Oct 17). Doi: 10.1097/j.pain.0000000000002804

Key clinical point: Adenosine vs placebo infusion increased headaches and short-lasting vasodilation without a significant induction of migraine attacks in patients with migraine without aura.

Major finding: The incidence of migraine attacks was not significantly different after adenosine vs placebo infusion (39% vs 17%; P = .29); however, a higher proportion of patients receiving adenosine vs placebo reported headache (78% vs 33%; P < .01). Adenosine vs placebo increased heart rate (area under the curve [AUC]_{T0-120 min}, P < .001), facial skin blood flow (AUC_{T0-120 min}, P < .05), and left superficial temporal artery diameter (AUC_{T0-20 min}, P = .01), but decreased middle cerebral artery blood flow velocity (AUC_{T0-20 min}, P < .001).

Study details: This randomized controlled trial included 18 patients with migraine without aura who received adenosine or placebo infusion over 20 minutes on two study days separated by a 1 week washout period.

Disclosures: This study received support from the Lundbeck Foundation. M Ashina reported receiving consulting fees, honoraria for lectures and presentations, and royalties from various sources, including Lundbeck.

Source: Thuraiaiyah J et al. Adenosine causes short-lasting vasodilation and headache, but not migraine attacks in migraine patients: A randomized clinical trial. Pain. 2022 (Oct 17). Doi: 10.1097/j.pain.0000000000002804

Key clinical point: Adenosine vs placebo infusion increased headaches and short-lasting vasodilation without a significant induction of migraine attacks in patients with migraine without aura.

Major finding: The incidence of migraine attacks was not significantly different after adenosine vs placebo infusion (39% vs 17%; P = .29); however, a higher proportion of patients receiving adenosine vs placebo reported headache (78% vs 33%; P < .01). Adenosine vs placebo increased heart rate (area under the curve [AUC]_{T0-120 min}, P < .001), facial skin blood flow (AUC_{T0-120 min}, P < .05), and left superficial temporal artery diameter (AUC_{T0-20 min}, P = .01), but decreased middle cerebral artery blood flow velocity (AUC_{T0-20 min}, P < .001).

Study details: This randomized controlled trial included 18 patients with migraine without aura who received adenosine or placebo infusion over 20 minutes on two study days separated by a 1 week washout period.

Disclosures: This study received support from the Lundbeck Foundation. M Ashina reported receiving consulting fees, honoraria for lectures and presentations, and royalties from various sources, including Lundbeck.

Source: Thuraiaiyah J et al. Adenosine causes short-lasting vasodilation and headache, but not migraine attacks in migraine patients: A randomized clinical trial. Pain. 2022 (Oct 17). Doi: 10.1097/j.pain.0000000000002804

Key clinical point: Individuals diagnosed with childhood cancer were at an increased risk for antimigraine medication and hospitalization due to migraine.

Major finding: Compared with unaffected individuals, those diagnosed with childhood cancer were at an elevated risk for initiating antimigraine therapy (standardized incidence ratios [SIR] 1.22; 95% CI 1.09-1.36) and hospitalization due to migraine (SIR 2.44; 95% CI 1.87-3.12), with the risk for initiating antimigraine therapy being the highest among individuals diagnosed with cancer at 15-19 years of age (SIR 1.48; 95% CI 1.25-1.74).

Study details: This was a population-based cohort study including individuals diagnosed with childhood cancer who had data available for antimigraine prescriptions (n = 6564) and migraine hospitalization (n = 7771).

Disclosures: This study was funded by Danmarks Frie Forskningsfond, Denmark. The authors declared no conflicts of interest.

Source: Davidsson OB et al. Childhood cancer confers increased risk of migraine – A Danish nationwide register study. Cancer Epidemiol. 2022;81:102278 (Oct 13). Doi: 10.1016/j.canep.2022.102278

Key clinical point: Individuals diagnosed with childhood cancer were at an increased risk for antimigraine medication and hospitalization due to migraine.

Major finding: Compared with unaffected individuals, those diagnosed with childhood cancer were at an elevated risk for initiating antimigraine therapy (standardized incidence ratios [SIR] 1.22; 95% CI 1.09-1.36) and hospitalization due to migraine (SIR 2.44; 95% CI 1.87-3.12), with the risk for initiating antimigraine therapy being the highest among individuals diagnosed with cancer at 15-19 years of age (SIR 1.48; 95% CI 1.25-1.74).

Study details: This was a population-based cohort study including individuals diagnosed with childhood cancer who had data available for antimigraine prescriptions (n = 6564) and migraine hospitalization (n = 7771).

Disclosures: This study was funded by Danmarks Frie Forskningsfond, Denmark. The authors declared no conflicts of interest.

Source: Davidsson OB et al. Childhood cancer confers increased risk of migraine – A Danish nationwide register study. Cancer Epidemiol. 2022;81:102278 (Oct 13). Doi: 10.1016/j.canep.2022.102278

Key clinical point: Individuals diagnosed with childhood cancer were at an increased risk for antimigraine medication and hospitalization due to migraine.

Major finding: Compared with unaffected individuals, those diagnosed with childhood cancer were at an elevated risk for initiating antimigraine therapy (standardized incidence ratios [SIR] 1.22; 95% CI 1.09-1.36) and hospitalization due to migraine (SIR 2.44; 95% CI 1.87-3.12), with the risk for initiating antimigraine therapy being the highest among individuals diagnosed with cancer at 15-19 years of age (SIR 1.48; 95% CI 1.25-1.74).

Study details: This was a population-based cohort study including individuals diagnosed with childhood cancer who had data available for antimigraine prescriptions (n = 6564) and migraine hospitalization (n = 7771).

Disclosures: This study was funded by Danmarks Frie Forskningsfond, Denmark. The authors declared no conflicts of interest.

Source: Davidsson OB et al. Childhood cancer confers increased risk of migraine – A Danish nationwide register study. Cancer Epidemiol. 2022;81:102278 (Oct 13). Doi: 10.1016/j.canep.2022.102278

Key clinical point: The presence of seemingly inert calcified lesions of neurocysticercosis (CLN) influences the course of migraine by increasing headache frequency, pain severity, and migraine-associated disability; however, patients with CLN showed a better response to amitriptyline treatment.

Major finding: In patients with vs without CLN, the headache frequency (P < .001), visual analog scale score (P < .001), and Migraine Disability Assessment score (P < .001) were significantly higher at baseline and not significantly different at 3 months after amitriptyline treatment; however, the magnitude of treatment response was significantly higher in patients with vs without CLN (P < .001).

Study details: This case-control study included age- and sex-matched patients with migraine with (n = 78) and without (n = 78) CLN on cranial computed tomography who received preventive treatment with amitriptyline.

Disclosures: The publication expenses were supported by the American Society of Tropical Medicine and Hygiene. RK Garg reported receiving royalties for writing UpToDate articles and an honorarium for writing for MedLink Neurology.

Source: Sharma K et al. Does calcified neurocysticercosis affect migraine characteristics and treatment responsiveness? A case-control study. Am J Trop Med Hyg. 2022 (Oct 10). Doi: 10.4269/ajtmh.22-0335

Key clinical point: The presence of seemingly inert calcified lesions of neurocysticercosis (CLN) influences the course of migraine by increasing headache frequency, pain severity, and migraine-associated disability; however, patients with CLN showed a better response to amitriptyline treatment.

Major finding: In patients with vs without CLN, the headache frequency (P < .001), visual analog scale score (P < .001), and Migraine Disability Assessment score (P < .001) were significantly higher at baseline and not significantly different at 3 months after amitriptyline treatment; however, the magnitude of treatment response was significantly higher in patients with vs without CLN (P < .001).

Study details: This case-control study included age- and sex-matched patients with migraine with (n = 78) and without (n = 78) CLN on cranial computed tomography who received preventive treatment with amitriptyline.

Disclosures: The publication expenses were supported by the American Society of Tropical Medicine and Hygiene. RK Garg reported receiving royalties for writing UpToDate articles and an honorarium for writing for MedLink Neurology.

Source: Sharma K et al. Does calcified neurocysticercosis affect migraine characteristics and treatment responsiveness? A case-control study. Am J Trop Med Hyg. 2022 (Oct 10). Doi: 10.4269/ajtmh.22-0335

Key clinical point: The presence of seemingly inert calcified lesions of neurocysticercosis (CLN) influences the course of migraine by increasing headache frequency, pain severity, and migraine-associated disability; however, patients with CLN showed a better response to amitriptyline treatment.

Major finding: In patients with vs without CLN, the headache frequency (P < .001), visual analog scale score (P < .001), and Migraine Disability Assessment score (P < .001) were significantly higher at baseline and not significantly different at 3 months after amitriptyline treatment; however, the magnitude of treatment response was significantly higher in patients with vs without CLN (P < .001).

Study details: This case-control study included age- and sex-matched patients with migraine with (n = 78) and without (n = 78) CLN on cranial computed tomography who received preventive treatment with amitriptyline.

Disclosures: The publication expenses were supported by the American Society of Tropical Medicine and Hygiene. RK Garg reported receiving royalties for writing UpToDate articles and an honorarium for writing for MedLink Neurology.

Source: Sharma K et al. Does calcified neurocysticercosis affect migraine characteristics and treatment responsiveness? A case-control study. Am J Trop Med Hyg. 2022 (Oct 10). Doi: 10.4269/ajtmh.22-0335

Key clinical point: Autonomic symptoms were prevalent in patients with episodic or chronic migraine but demonstrated no significant correlation with headache frequency, treatment response, or reversion from chronic to episodic migraine.

Major finding: Overall, 60.5% of patients reported a Composite Autonomic Symptom Scale (COMPASS-31) score of ≥30. The median monthly headache days (P = .002) and Migraine Disability Assessment Score (P = .01) reduced significantly during the study period but change in the mean weighted COMPASS-31 score was not significant (P = .885), with no correlation observed between the COMPASS-31 score and monthly headache frequency or reversion from chronic to episodic migraine.

Study details: This was a prospective longitudinal cohort study including 43 patients with episodic or chronic migraine who completed 12 months of treatment and follow-up surveys.

Disclosures: This study did not report the source of funding. Four authors declared receiving funding, grants, or payment for developing educational presentations, serving on advisory boards, or being involved in clinical trials sponsored by various sources.

Source: Ray JC et al. Autonomic symptoms in migraine: Results of a prospective longitudinal study. Front Neurol. 2022;13:1036798 (Nov 3). Doi: 10.3389/fneur.2022.1036798

Key clinical point: Autonomic symptoms were prevalent in patients with episodic or chronic migraine but demonstrated no significant correlation with headache frequency, treatment response, or reversion from chronic to episodic migraine.

Major finding: Overall, 60.5% of patients reported a Composite Autonomic Symptom Scale (COMPASS-31) score of ≥30. The median monthly headache days (P = .002) and Migraine Disability Assessment Score (P = .01) reduced significantly during the study period but change in the mean weighted COMPASS-31 score was not significant (P = .885), with no correlation observed between the COMPASS-31 score and monthly headache frequency or reversion from chronic to episodic migraine.

Study details: This was a prospective longitudinal cohort study including 43 patients with episodic or chronic migraine who completed 12 months of treatment and follow-up surveys.

Disclosures: This study did not report the source of funding. Four authors declared receiving funding, grants, or payment for developing educational presentations, serving on advisory boards, or being involved in clinical trials sponsored by various sources.

Source: Ray JC et al. Autonomic symptoms in migraine: Results of a prospective longitudinal study. Front Neurol. 2022;13:1036798 (Nov 3). Doi: 10.3389/fneur.2022.1036798

Key clinical point: Autonomic symptoms were prevalent in patients with episodic or chronic migraine but demonstrated no significant correlation with headache frequency, treatment response, or reversion from chronic to episodic migraine.

Major finding: Overall, 60.5% of patients reported a Composite Autonomic Symptom Scale (COMPASS-31) score of ≥30. The median monthly headache days (P = .002) and Migraine Disability Assessment Score (P = .01) reduced significantly during the study period but change in the mean weighted COMPASS-31 score was not significant (P = .885), with no correlation observed between the COMPASS-31 score and monthly headache frequency or reversion from chronic to episodic migraine.

Study details: This was a prospective longitudinal cohort study including 43 patients with episodic or chronic migraine who completed 12 months of treatment and follow-up surveys.

Disclosures: This study did not report the source of funding. Four authors declared receiving funding, grants, or payment for developing educational presentations, serving on advisory boards, or being involved in clinical trials sponsored by various sources.

Source: Ray JC et al. Autonomic symptoms in migraine: Results of a prospective longitudinal study. Front Neurol. 2022;13:1036798 (Nov 3). Doi: 10.3389/fneur.2022.1036798

Key clinical point: During acute headaches, patients with migraine had elevated levels of peripheral inflammatory markers (PIM), specifically the neutrophil-to-lymphocyte ratio (NLR) and the neutrophil-to-monocyte ratio (NMR), which could fairly differentiate between the migraine and no headache groups.

Major finding: Patients with migraine had higher NLR, NMR, and monocyte-to-lymphocyte ratio (all P < .001) compared with control individuals without headache and higher NMR (P < .001) and higher NLR (P = .051) compared with patients with non-migraine headaches during acute headache attacks. NLR and NMR could fairly differentiate between the migraine and no headache groups (NLR: area under the curve [AUC] 0.65; NMR: AUC 0.61; P < .001).

Study details: This was a retrospective analysis of 4005 patients with acute headache attack, including those with migraine (n = 1453) or non-migraine (n = 2552) headaches, and 88,586 control individuals without headache.

Disclosures: This study was supported by Basic Science Research Program through the National Research Foundataion of Korea funded by the Ministry of Education and others. The authors declared no conflicts of interest.

Source: Lee S-H et al. Role of peripheral inflammatory markers in patients with acute headache attack to differentiate between migraine and non-migraine headache. J Clin Med. 2022;11(21):6538 (Nov 3). Doi: 10.3390/jcm11216538

Key clinical point: During acute headaches, patients with migraine had elevated levels of peripheral inflammatory markers (PIM), specifically the neutrophil-to-lymphocyte ratio (NLR) and the neutrophil-to-monocyte ratio (NMR), which could fairly differentiate between the migraine and no headache groups.

Major finding: Patients with migraine had higher NLR, NMR, and monocyte-to-lymphocyte ratio (all P < .001) compared with control individuals without headache and higher NMR (P < .001) and higher NLR (P = .051) compared with patients with non-migraine headaches during acute headache attacks. NLR and NMR could fairly differentiate between the migraine and no headache groups (NLR: area under the curve [AUC] 0.65; NMR: AUC 0.61; P < .001).

Study details: This was a retrospective analysis of 4005 patients with acute headache attack, including those with migraine (n = 1453) or non-migraine (n = 2552) headaches, and 88,586 control individuals without headache.

Disclosures: This study was supported by Basic Science Research Program through the National Research Foundataion of Korea funded by the Ministry of Education and others. The authors declared no conflicts of interest.

Source: Lee S-H et al. Role of peripheral inflammatory markers in patients with acute headache attack to differentiate between migraine and non-migraine headache. J Clin Med. 2022;11(21):6538 (Nov 3). Doi: 10.3390/jcm11216538

Key clinical point: During acute headaches, patients with migraine had elevated levels of peripheral inflammatory markers (PIM), specifically the neutrophil-to-lymphocyte ratio (NLR) and the neutrophil-to-monocyte ratio (NMR), which could fairly differentiate between the migraine and no headache groups.

Major finding: Patients with migraine had higher NLR, NMR, and monocyte-to-lymphocyte ratio (all P < .001) compared with control individuals without headache and higher NMR (P < .001) and higher NLR (P = .051) compared with patients with non-migraine headaches during acute headache attacks. NLR and NMR could fairly differentiate between the migraine and no headache groups (NLR: area under the curve [AUC] 0.65; NMR: AUC 0.61; P < .001).

Study details: This was a retrospective analysis of 4005 patients with acute headache attack, including those with migraine (n = 1453) or non-migraine (n = 2552) headaches, and 88,586 control individuals without headache.

Disclosures: This study was supported by Basic Science Research Program through the National Research Foundataion of Korea funded by the Ministry of Education and others. The authors declared no conflicts of interest.

Source: Lee S-H et al. Role of peripheral inflammatory markers in patients with acute headache attack to differentiate between migraine and non-migraine headache. J Clin Med. 2022;11(21):6538 (Nov 3). Doi: 10.3390/jcm11216538

Key clinical point: Migraine pain characteristics indicating peripheral or central sensitization may help predict ≥50% response to anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: In HFEM, unilateral pain (UP) + unilateral cranial autonomic symptoms (UA) positively predicted ≥50% response (odds ratio [OR] 4.23; P = .004), whereas in CM, UP (OR 1.46; P = .039), UA (OR 1.49; P = .026), UP+UA (OR 1.90; P = .012), and UP+allodynia (OR 1.71; P = .034) positively predicted ≥50% response and obesity negatively predicted ≥50% response (OR 0.21; P = .006).

Study details: This was a real-life prospective cohort study including 864 anti-CGRP mAb-naive patients with HFEM or CM and unresponsiveness or contraindications for or low tolerability to >3 migraine preventive medications, who were prescribed erenumab, galcanezumab, or fremanezumab for ≥24 weeks.

Disclosures: This study was partially supported by the Italian Ministry of Health IRCCS San Raffaele Roma. Several authors reported receiving personal compensation, travel grants, honoraria, or research support from various sources.

Source: Barbanti P et al. Predictors of response to anti-CGRP monoclonal antibodies: A 24-week, multicenter, prospective study on 864 migraine patients. J Headache Pain. 2022;23:138 (Nov 1). Doi: 10.1186/s10194-022-01498-6

Key clinical point: Migraine pain characteristics indicating peripheral or central sensitization may help predict ≥50% response to anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: In HFEM, unilateral pain (UP) + unilateral cranial autonomic symptoms (UA) positively predicted ≥50% response (odds ratio [OR] 4.23; P = .004), whereas in CM, UP (OR 1.46; P = .039), UA (OR 1.49; P = .026), UP+UA (OR 1.90; P = .012), and UP+allodynia (OR 1.71; P = .034) positively predicted ≥50% response and obesity negatively predicted ≥50% response (OR 0.21; P = .006).

Study details: This was a real-life prospective cohort study including 864 anti-CGRP mAb-naive patients with HFEM or CM and unresponsiveness or contraindications for or low tolerability to >3 migraine preventive medications, who were prescribed erenumab, galcanezumab, or fremanezumab for ≥24 weeks.

Disclosures: This study was partially supported by the Italian Ministry of Health IRCCS San Raffaele Roma. Several authors reported receiving personal compensation, travel grants, honoraria, or research support from various sources.

Source: Barbanti P et al. Predictors of response to anti-CGRP monoclonal antibodies: A 24-week, multicenter, prospective study on 864 migraine patients. J Headache Pain. 2022;23:138 (Nov 1). Doi: 10.1186/s10194-022-01498-6

Key clinical point: Migraine pain characteristics indicating peripheral or central sensitization may help predict ≥50% response to anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: In HFEM, unilateral pain (UP) + unilateral cranial autonomic symptoms (UA) positively predicted ≥50% response (odds ratio [OR] 4.23; P = .004), whereas in CM, UP (OR 1.46; P = .039), UA (OR 1.49; P = .026), UP+UA (OR 1.90; P = .012), and UP+allodynia (OR 1.71; P = .034) positively predicted ≥50% response and obesity negatively predicted ≥50% response (OR 0.21; P = .006).

Study details: This was a real-life prospective cohort study including 864 anti-CGRP mAb-naive patients with HFEM or CM and unresponsiveness or contraindications for or low tolerability to >3 migraine preventive medications, who were prescribed erenumab, galcanezumab, or fremanezumab for ≥24 weeks.

Disclosures: This study was partially supported by the Italian Ministry of Health IRCCS San Raffaele Roma. Several authors reported receiving personal compensation, travel grants, honoraria, or research support from various sources.

Source: Barbanti P et al. Predictors of response to anti-CGRP monoclonal antibodies: A 24-week, multicenter, prospective study on 864 migraine patients. J Headache Pain. 2022;23:138 (Nov 1). Doi: 10.1186/s10194-022-01498-6

Key clinical point: Despite no significant improvement in pain-free status, high-dose zolmitriptan nasal spray (ZNS) provided clinically relevant improvements with a favorable safety profile in the acute treatment of migraine in patients aged 6-11 years.

Major finding: At 2 hours postdose, high-dose ZNS vs placebo led to a numerically higher proportion of patients achieving pain-free status (odds ratio [OR] 1.51; 95% CI 0.96-2.38) and a significantly higher proportion of patients reporting a headache response (OR 1.75; P = .009). No serious treatment-emergent adverse events were reported.

Study details: This was a phase 3 crossover trial with an open-label extension including 186 patients aged 6-11 years with migraine with or without aura who were randomly assigned to receive ZNS (patients <50 kg: 2.5 or 1 mg; patients ≥50 kg: 5 or 2.5 mg) or placebo.

Disclosures: This trial was funded by AstraZeneca and conducted by Amneal Pharmaceuticals LLC, which also supported the study’s publication. Two authors declared being employees of Amneal or a company contracted by Amneal. Two authors reported ties with various other sources.

Source: Yonker ME et al. A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the efficacy and safety of zolmitriptan nasal spray for the acute treatment of migraine in patients aged 6 to 11 years, with an open-label extension. Headache. 2022;62(9):1207-1217 (Oct 26). Doi: 10.1111/head.14391

Key clinical point: Despite no significant improvement in pain-free status, high-dose zolmitriptan nasal spray (ZNS) provided clinically relevant improvements with a favorable safety profile in the acute treatment of migraine in patients aged 6-11 years.

Major finding: At 2 hours postdose, high-dose ZNS vs placebo led to a numerically higher proportion of patients achieving pain-free status (odds ratio [OR] 1.51; 95% CI 0.96-2.38) and a significantly higher proportion of patients reporting a headache response (OR 1.75; P = .009). No serious treatment-emergent adverse events were reported.

Study details: This was a phase 3 crossover trial with an open-label extension including 186 patients aged 6-11 years with migraine with or without aura who were randomly assigned to receive ZNS (patients <50 kg: 2.5 or 1 mg; patients ≥50 kg: 5 or 2.5 mg) or placebo.

Disclosures: This trial was funded by AstraZeneca and conducted by Amneal Pharmaceuticals LLC, which also supported the study’s publication. Two authors declared being employees of Amneal or a company contracted by Amneal. Two authors reported ties with various other sources.

Source: Yonker ME et al. A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the efficacy and safety of zolmitriptan nasal spray for the acute treatment of migraine in patients aged 6 to 11 years, with an open-label extension. Headache. 2022;62(9):1207-1217 (Oct 26). Doi: 10.1111/head.14391

Key clinical point: Despite no significant improvement in pain-free status, high-dose zolmitriptan nasal spray (ZNS) provided clinically relevant improvements with a favorable safety profile in the acute treatment of migraine in patients aged 6-11 years.

Major finding: At 2 hours postdose, high-dose ZNS vs placebo led to a numerically higher proportion of patients achieving pain-free status (odds ratio [OR] 1.51; 95% CI 0.96-2.38) and a significantly higher proportion of patients reporting a headache response (OR 1.75; P = .009). No serious treatment-emergent adverse events were reported.

Study details: This was a phase 3 crossover trial with an open-label extension including 186 patients aged 6-11 years with migraine with or without aura who were randomly assigned to receive ZNS (patients <50 kg: 2.5 or 1 mg; patients ≥50 kg: 5 or 2.5 mg) or placebo.

Disclosures: This trial was funded by AstraZeneca and conducted by Amneal Pharmaceuticals LLC, which also supported the study’s publication. Two authors declared being employees of Amneal or a company contracted by Amneal. Two authors reported ties with various other sources.

Source: Yonker ME et al. A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the efficacy and safety of zolmitriptan nasal spray for the acute treatment of migraine in patients aged 6 to 11 years, with an open-label extension. Headache. 2022;62(9):1207-1217 (Oct 26). Doi: 10.1111/head.14391

Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.

Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.

Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.

Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.

Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389

Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.

Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.

Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.

Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.

Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389

Key clinical point: A single dose of zavegepant nasal spray (20 or 10 mg) was effective for the acute treatment of migraine with a favorable safety profile.

Major finding: At 2 hours, a significantly higher proportion of patients treated with 20 mg or 10 mg zavegepant vs placebo reported freedom from pain (23.1% and 22.5% vs 15.5%; P = .0055 and .0113, respectively) and most bothersome symptoms (42.5% and 41.9% vs 33.7%; P = .0094 and .0155, respectively), with adverse events being mostly mild or moderate and no indications for hepatotoxicity.

Study details: This phase 2/3 trial included 1673 patients with migraine with or without aura who were randomly assigned to receive zavegepant (5, 10, 20 mg) or placebo to treat a single migraine attack of moderate-to-severe pain intensity.

Disclosures: This study was funded by Biohaven Pharmaceuticals, Inc. Seven authors declared being employees and holding stock or stock options in Biohaven Pharmaceuticals. RB Lipton declared holding stock options in Biohaven Pharmaceuticals and Manistee and reported ties with various other sources.

Source: Croop R et al. Zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153-1163 (Oct 14). Doi: 10.1111/head.14389

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940

Key clinical point: The odds of anxiety and depression disorders were significantly higher in children and adolescents with migraine compared with control individuals, highlighting the need to routinely screen children and adolescents with migraine for anxiety and depression.

Major finding: Children and adolescents with migraine vs control individuals were at a higher risk for anxiety disorders (odds ratio [OR] 1.93; 95% CI 1.49-2.50), depressive disorders (OR 2.01; 95% CI 1.46-2.78), and mixed internalizing (anxiety and depressive) disorders (OR 4.69; 95% CI 3.08-7.14).

Study details: This was a systematic review of 80 observational studies, of which 51 involving children and adolescents with migraine and control individuals were included in the meta-analysis.

Disclosures: This study was supported by the Alberta Children’s Hospital Research Institute (ACHRI) and Cumming School of Medicine, Canada. SL Orr reported receiving royalties for book publication, grant funding from the Canadian Health Research and ACHRI, and serving on the editorial boards of journals and the American Migraine Foundation.

Source: Falla K et al. Anxiety and depressive symptoms and disorders in children and adolescents with migraine: A systematic review and meta-analysis. JAMA Pediatr. 2022 (Oct 31). Doi: 10.1001/jamapediatrics.2022.3940