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 withSeglor 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.
RCT Entities:
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 migrainepatients 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.
Authors: M Lantéri-Minet; H Alchaar; G Besson; F Billé-Turc; J Bouillat; F Brudon; A Donnet; P Galletti; M Maitre; Y Moene; G Rambaud; C Rostini; J Valance; J L Gastaut Journal: Rev Neurol (Paris) Date: 2000-12 Impact factor: 2.607
Authors: H C Diener; M Föh; C Iaccarino; P Wessely; H Isler; H Strenge; M Fischer; W Wedekind; Z Taneri Journal: Cephalalgia Date: 1996-10 Impact factor: 6.292
Authors: N Martucci; V Manna; P Mattesi; G Troiani; G C Manzoni; M Lanfranchi; G Bono; G Micieli Journal: Cephalalgia Date: 1983-08 Impact factor: 6.292
Authors: Paola Sarchielli; Franco Granella; Maria Pia Prudenzano; Luigi Alberto Pini; Vincenzo Guidetti; Giorgio Bono; Lorenzo Pinessi; Massimo Alessandri; Fabio Antonaci; Marcello Fanciullacci; Anna Ferrari; Mario Guazzelli; Giuseppe Nappi; Grazia Sances; Giorgio Sandrini; Lidia Savi; Cristina Tassorelli; Giorgio Zanchin Journal: J Headache Pain Date: 2012-05 Impact factor: 7.277