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© 2007 American Academy of Neurology Zolmitriptan nasal spray in the acute treatment of cluster headacheA double-blind studyFrom the Department of Neurology, David Geffen School of Medicine at UCLA (A.M.R.), Los Angeles, CA; The New England Center for Headache (A.M.R., S.J.T., F.D.S., M.E.B.), Stamford, CT; Houston Headache Clinic (N.T.M.), Houston, TX; Jefferson Headache Center and Thomas Jefferson University (S.D.S.), Philadelphia, PA; Department of Neurology, Mayo Clinic College of Medicine (D.D.), Scottsdale, AZ; Department of Neurology, Yale School of Medicine (S.J.T.), New Haven, CT; and Department of Neurology, Albert Einstein College of Medicine (M.E.B.), Bronx, NY. Address correspondence and reprint requests to Dr. Alan M. Rapoport, 84 Farms Road, Stamford, CT 06903 alanrapoport{at}gmail.com Objective: To evaluate the efficacy and tolerability of zolmitriptan 5 mg and 10 mg nasal spray (ZNS) vs placebo in the acute treatment of cluster headache. Design/Methods: We conducted a multicenter, double-blind, randomized, three-period crossover study using ZNS 5 mg, ZNS 10 mg, and placebo. Headache intensity was rated by a 5-point scale: none, mild, moderate, severe, or very severe. The primary efficacy measure was headache response (pain reduced from moderate, severe, or very severe at baseline, to mild or none) at 30 minutes. Logistic regression was used to account for treatment period effect as well as for cluster headache subtype effect. Results: A total of 52 adult patients treated 151 attacks. For the primary endpoint, both doses reached significance at 30 minutes (placebo = 30%, ZNS 5 mg = 50%, ZNS 10 mg = 63.3%). For headache relief, ZNS 10 mg separated from placebo at 10 minutes (24.5% vs 10%). Zolmitriptan 5 mg separated from placebo at 20 minutes (38.5% vs 20%). For pain-free status, ZNS 10 mg was superior to placebo at 15 minutes (22.0% vs 6%). Both doses had higher pain-free rates than placebo at 30 minutes (placebo = 20%, ZNS 5 mg = 38.5%, ZNS 10 mg = 46.9%). Side effects were mild and seen in 16% of those attacks treated with placebo, 25% of attacks treated with ZNS 5 mg, and 32.7% treated with ZNS 10 mg. Conclusions/Relevance: Zolmitriptan nasal spray, at doses of 5 and 10 mg, is effective and tolerable for the acute treatment of cluster headache.
Disclosures: This clinical trial was conducted as an Investigator Initiated Grant, initiated from The New England Center for Headache and sponsored by AstraZeneca. AstraZeneca also provided drug. The conduct of the study, data collection, analyses, and writing are the full responsibility of the authors. None of the authors has a conflict in reference to this study. Each author has received grants to conduct this study, and each has received grants and honoraria and has been on advisory boards of multiple pharmaceutical companies. Received January 2, 2007. Accepted in final form March 14, 2007. This article has been cited by other articles:
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