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


CONCLUSIONS
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.
Pradalier
André
A
Centre Migraines et Céphalées, Louis Mourier Hospital, Colombes, France. secretariat.medecine4@lmr.ap-hop-paris.fr
Lantéri-Minet
Michel
M
Géraud
Gilles
G
Allain
Hervé
H
Lucas
Christian
C
Delgado
Antonio
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D004087:Dihydroergotamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D011320:Primary Health Care; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D014662:Vasoconstrictor Agents; D004087:Dihydroergotamine