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Pain Free Efficacy of Sumatriptan in the Treatment of
Menstrually-Associated Migraine
Robert Nett, MD, Steve Shackelford, DVM,
Mary Richardson, Pharm.D.
Posted November 2002  
Presented at: AHS Conference, Seattle, WA, June 21-23, 2003

Background:   87% of migraineurs questioned in a recent survey felt that the ability to provide complete freedom from pain was the most important attribute of a migraine medication. Two prospective trials have established that sumatriptan 50 and 100 mg. tablets provide complete freedom from pain in the acute treatment of migraine attacks when taken during the mild pain phase. Those trials suggested that early treatment is also effective for menstrually-associated migraine (MAM) attacks. However, the number of MAMs treated was small.

Objective:   To determine the efficacy of sumatriptan 50 mg. and 100 mg. tablets in menstrually-associated migraine (MAM) when treatment is administered during the mild pain phase.

Methods:   A randomized, double-blind, placebo-controlled, single-attack study was conducted at 39 centers in the United States, Canada and Puerto Rico.

Female subjects 18-65 years of age, with at least a 1-year history of migraine, a 6-month history of regularly occurring MAM, and who experienced moderate to severe MAM pain preceded by a mild pain phase were eligible.

MAM was defined as any migraine beginning on or between day 2 and day 4, with day 1=first day of flow.

Sumatriptan tablets or matching placebo were administered during the mild pain phase of a migraine (when headache pain was grade 1 on a 4-point scale) in a double dummy fashion to provide 3 dose groups: sumatriptan 50 mg., sumatriptan 100 mg., and placebo.

Subjects treated attacks within 1 hour of the onset of pain but only if the pain was mild at onset and while the pain was still midl.

The primary study endpoint was the efficacy of sumatriptan 100 mg. tablets as measured by the percentage of subjects experiencing complete relief of pain (i.e., grade 1 reducted to grade 0) 2 hours after treatment.

Conclusions:   Sumatriptan 50 mg. and 100 mg. tablets are well tolerated and effective in providing freedom from pain and associated symptoms of menstrually associated migraine, when administered in the mild pain phase.