Published online August 1, 2007
PEDIATRICS Vol. 120 No. 2 August 2007, pp. 390-396 (doi:10.1542/10.1542/peds.2007-0085)
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ARTICLE

Efficacy of Zolmitriptan Nasal Spray in Adolescent Migraine

Donald W. Lewis, MD, FAAN, FAAPa, Paul Winner, DO, FAAN, FAAPb, Andrew D. Hershey, MD, PhDc,d, Warren W. Wasiewski, MDe on behalf of the Adolescent Migraine Steering Committee

a Division of Pediatric Neurology, Children's Hospital of the King's Daughters, Norfolk, Virginia
b Palm Beach Headache Center, West Palm Beach, Florida
c Divisions of Pediatrics
d Neurology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio
e AstraZeneca, Wilmington, Delaware

OBJECTIVE. The goal was to evaluate the efficacy and tolerability of zolmitriptan nasal spray in the treatment of adolescent migraine.

METHODS. The "Double-Diamond" study used a novel, single-blind, "placebo challenge" in a multicenter, randomized, double-blind, placebo-controlled, 2-way, 2-attack, crossover design. A total of 248 US adolescent patients (12–17 years of age) with an established diagnosis of migraine, with or without aura, were enrolled. A single-blind placebo challenge was used for each migraine attack. No additional medications were taken if a headache response to the initial placebo treatment was achieved at 15 minutes; if migraine intensity remained moderate or severe, then patients treated the attack with zolmitriptan (5 mg) nasal spray or placebo according to a randomized, crossover schedule (double-blind). The primary efficacy variable was headache response at 1 hour after treatment. A comprehensive range of secondary end points included sustained headache response at 2 hours.

RESULTS. A total of 171 patients (mean age: 14.2 years; 57.3% female) treated ≥1 attack with study medication (intention-to-treat population). The onset of significant pain relief was apparent 15 minutes after treatment with zolmitriptan nasal spray. At 1 hour after the dose, zolmitriptan nasal spray produced a higher headache response rate than did placebo (58.1% vs 43.3%). Zolmitriptan nasal spray was also significantly superior to placebo in improvement in pain intensity, pain-free rates, sustained resolution of headache, and resolution of associated migraine symptoms. Return to normal activities was also consistently faster with zolmitriptan nasal spray than with placebo, with less use of any escape medication. Treatment with zolmitriptan nasal spray was well tolerated.

CONCLUSIONS. This novel, placebo-challenge study demonstrated that zolmitriptan nasal spray was well tolerated and provided fast and significantly effective relief of migraine symptoms in the acute treatment of adolescent migraine.

Key Words: adolescent migraine • zolmitriptan nasal spray • efficacy • tolerability

Abbreviations: CI—confidence interval • FDA—Food and Drug Administration • ITT—intention-to-treat • NS—nasal spray • OR—odds ratio

Accepted Mar 26, 2007.


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Zolmitriptan Nasal Spray for Migraines in Adolescents
Journal Watch Pediatrics and Adolescent Medicine, August 6, 2007; 2007(806): 2 - 2.
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