Efficacy of Pregabalin in Migraine Prevention

• Status: Withdrawn
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Militar del General Luis Felipe Brieba Aran
• Treatments: Pregabalin; Valproic Acid

Criteria

Inclusion Criteria:

• Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.

• Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.

• Available for follow-up at least 9 months.

Exclusion criteria:

• Patients with headache others than migraine.

• Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.

• Prophylactic drugs for migraine 12 weeks before randomization.

• Onset of migraine occurred after 50 years.

• Hypersensitivity to pregabalin or sodium valproate.