Efficacy of Pregabalin in Migraine Prevention

Phase 3

Withdrawn

• Conditions: Migraine Disorders

• Registration Number: NCT00447369
• Lead Sponsor: Hospital Militar del General Luis Felipe Brieba Aran

Brief 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.

Detailed Description

The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.

Study Timeline

• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Study Start: 2007-05
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 70

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
days with migraine

Secondary Outcome Measures

Name	Time	Method
hours with migraine
headache severity index
level of disability
reports of adverse events

Trial Locations

Locations (1)

Hospital Militar del General Luis Felipe Brieba Aran; 🇨🇱 Santiago, Reg. Metropolitana, Chile