Zomig Nasal Spray Found Effective for Cluster Headaches

By Teri Robert, Lead Expert

A study to be published in the August 28 issue of Neurology, the journal of the American Academy of Neurology, reports Zomig (zolmitriptan) Nasal Spray to be effective for rapid treatment of cluster headaches.

“This is a significant finding and the main endpoint of our study. The 10 milligram dose worked as quickly as 10 minutes in some patients… Cluster headache is an extremely severe headache disorder with enormous unmet treatment needs. Few medications for cluster headache have been systematically tested, and only one, which involves an injection of sumatriptan (Imitrex), has been FDA approved… Because a cluster headache attack builds up to a crescendo within five to 15 minutes, treatment must be rapid and offer significant relief. While the FDA has not approved zolmitriptan nasal spray for use in cluster headaches, it may someday be considered a first-line therapy.”1

Alan M. Rapoport, MD,

Director Emeritus, The New England Center for Headache

Clinical Professor of Neurology, The David Geffen School of Medicine at UCLA

Cluster headaches (CH) are often said to be the most painful of all headaches. They have been described as "boring," bearing, burning," "like a hot poker in the eye," and as "suicide headaches." The age of onset of cluster headaches is most often between the ages of 20 and 40, and they are more common in men than women at a ratio of 2:1.

Zomig is a triptan medication originally developed as a Migraine abortive medication. It received FDA approval for the acute treatment of Migraine on September 30, 2003, and is manufactured by AstraZeneca.

 

Study 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.” 2

 

Study methods

  • The study included 52 people with cluster headaches to treat 151 separate cluster attacks.
  • ZNS 5 mg, ZNS 10 mg, and placebo were utilized.
  • This was a double-blind study in which neither the patients nor the study staff knew which participants were receiving ZNS and which were receiving placebo.
  • For this study, headache intensity was rated by a 5-point scale: none, mild, moderate, severe, or very severe.
  • Efficacy was based on headache response 30 minutes after use of ZNS – pain reduced from moderate, severe, or very severe when dosing to mild or none.
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