Alpha-dihydroergocryptine in the prophylaxis of migraine: a multicenter double-blind study versus flunarizine.

Abstract

This multicenter, double-blind, clinical study was designed to compare the efficacy and safety of alpha-dihydroergocryptine and flunarizine in the prophylaxis of migraine without aura. One hundred thirty-five patients fulfilling the diagnostic criteria of the International Headache Society were enrolled at five neurologic centers. The study design included a 1-month pretreatment phase with placebo; a 6-month, double-blind, double-dummy treatment phase with alpha-dihydroergocryptine (10 mg twice daily) or flunarizine (5 mg once daily); a further 3-month follow-up phase without treatment. Efficacy was assessed using the patient's diary. Laboratory tests, vital signs, and adverse events were monitored. Analysis of covariance for repeated measures was performed on the intent-to-treat sample. Both treatments led to a significant reduction in the frequency of migraine, days with headache, and use of relief medication. Overall, 51% of those treated with alpha-dihydroergocryptine and 49% of those treated with flunarizine were responders (50% or greater reduction in attack frequency), the average percentage of reduction being 64% with alpha-dihydroergocryptine and 51% with flunarizine. There was no significant difference between the two groups in terms of incidence of adverse events; dizziness and weight gain were the most frequent observed adverse events with alpha-dihydroergocryptine and flunarizine, respectively. Based on the overall improvement in migraine parameters, alpha-dihydroergocryptine can be recommended for use in migraine prophylaxis.

• Authors: G Bussone, R Cerbo, N Martucci, G Micieli, C Zanferrari, L Grazzi, G Fabbrini, A Cavallini, F Granella, L Ambrosoli, F Mailland, A Poli, G Manzoni
• Journal: Headache (Headache) Vol. 39 Issue 6 Pg. 426-31 (Jun 1999) ISSN: 0017-8748 [Print] United States
• PMID: 11279920 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dihydroergotoxine
• Flunarizine

Topics

• Adult
• Dihydroergotoxine (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Flunarizine (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Recurrence
• Treatment Outcome