, Volume 18, Issue 15, pp 1149-1163
Date: 29 Aug 2012

The PROMISE Study: PROphylaxis of Migraine with SEglor® (Dihydroergotamine Mesilate) in French Primary Care

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Abstract

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.