The PROMISE study: PROphylaxis of MIgraine with SEglor (dihydroergotamine mesilate) in French primary care.

Author(s): Pradalier A, Lanteri-Minet M, Geraud G, Allain H, Lucas C, Delgado A

Affiliation(s): Centre Migraines et Cephalees, Louis Mourier Hospital, Colombes, France. secretariat.medecine4@lmr.ap-hop-paris.fr

Publication date & source: 2004, CNS Drugs., 18(15):1149-63.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

INTRODUCTION: Seglor capsules, a unique modified-release formulation of dihydroergotamine mesilate, have long been in clinical use in France for migraine prophylaxis. The aim of the PROMISE (PROphylaxis of MIgraine with SEglor) study was to establish the efficacy and tolerability of Seglor in the prevention of migraine in a general practice setting. METHODS: The PROMISE study was a double blind, placebo-controlled, parallel-group study carried out in primary care practice. It included 363 migraine patients treated with Seglor or placebo for 5 months after a 1-month placebo run-in phase. RESULTS: Migraine attack frequency (primary efficacy criterion) decreased markedly in the two treatment groups so that the difference in favour of Seglor did not reach statistical significance. However, most secondary outcome measures (duration of single attack, total duration of attacks over 1 month, consumption of mild opiate analgesics, subjective improvement) improved to a significantly greater degree in patients receiving Seglor than in those receiving placebo. In the 84.5% of patients who had impaired quality of life at entry, the percentage of reduction in attack frequency and most other efficacy measures showed significant improvement with Seglor. The safety profile for Seglor was comparable to that of placebo. CONCLUSION: These results support the effectiveness of Seglor in patients with migraine-related quality-of-life impairment. The findings of the PROMISE study also suggest that patients' quality of life should be assessed systematically before initiating a preventive treatment for migraine.