A Randomized, Double-Blind, Placebo-Controlled Study of Sumatriptan Nasal Spray in the Treatment of Acute Migraine in Adolescents

• Published in: Pediatrics (Evanston) 2000-11, Vol.106 (5), p.989-997
• Main Authors: Winner, Paul, Rothner, A. David, Saper, Joel, Nett, Robert, Asgharnejad, Mahnaz, Laurenza, Antonio, Austin, Randall, Peykamian, Margaret
• Format: Article
• Language: English
• Subjects: Acute Disease; Administration, Intranasal; Adolescent; Adult; Age Factors; Analgesics; Biological and medical sciences; Child; Dosage and administration; Double-Blind Method; Drug therapy; Evaluation; Female; Humans; Intranasal medication; Male; Medical sciences; Migraine; Migraine Disorders - drug therapy; Nasal sprays; Neuropharmacology; Nose; Pediatrics; Pharmaceuticals; Pharmacology. Drug treatments; Placebos; Sumatriptan; Sumatriptan - administration & dosage; Sumatriptan - therapeutic use; Teenagers; Treatment Outcome
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.106.5.989

To compare the efficacy and tolerability of sumatriptan nasal spray (NS; 5 mg, 10 mg, and 20 mg) with placebo for the treatment of acute migraine in adolescents. A randomized, double-blind, placebo-controlled, single-attack study was conducted in 653 US adolescents (12-17 years of age). Patients with at least a 6-month history of migraine, who met International Headache Society criteria for migraine (with or without aura) were eligible for participation. Headache relief 2 hours postdose, complete relief, presence or absence of associated symptoms, headache recurrence, and use of rescue medications were recorded. The primary efficacy endpoint was headache relief 2 hours postdose sumatriptan NS (20 mg) versus placebo. Safety and tolerability were assessed by examining adverse events, changes in electrocardiograms, vital signs, physical examinations, and clinical laboratory tests. Headache relief 1 hour postdose was significantly greater for patients using 10 mg (56%) and 20 mg (56%) of sumatriptan NS compared with placebo (41%). Headache relief 2 hours postdose was significantly greater for patients using 5 mg of sumatriptan NS (66%) compared with placebo (53%), and approached statistical significance for 20 mg (63%) compared with placebo (53%). Complete relief 2 hours postdose was significantly greater for patients using 20 mg of sumatriptan NS compared with placebo (36% vs 25%, respectively). Each dose of sumatriptan (5 mg, 10 mg, and 20 mg) was superior to placebo with respect to the cumulative percentages of patients first reporting headache relief within 2 hours of dosing (Kaplan-Meier). The sumatriptan 20-mg dose was superior to placebo with respect to the cumulative percentages of patients first reporting complete relief within 2 hours of dosing (Kaplan-Meier). Photophobia and phonophobia were significantly reduced 2 hours postdose for sumatriptan NS (20 mg), compared with placebo (36% vs 48% and 25% vs 44%, respectively). Taste disturbance was the most commonly reported adverse event (2%, 19%, 30%, and 26% for placebo, 5 mg, 10 mg, and 20 mg, respectively). No drug-related serious adverse events or clinically relevant changes in laboratory parameters, electrocardiograms, or vital signs were reported. Sumatriptan NS is effective and well-tolerated for the treatment of acute migraine in adolescents, with the 20-mg dose providing the best overall efficacy and tolerability profiles.