Status:
WITHDRAWN
Efficacy of Pregabalin in Migraine Prevention
Lead Sponsor:
Hospital Militar del General Luis Felipe Brieba Aran
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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. Be...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00447369
Start Date
May 1 2007
End Date
March 1 2008
Last Update
May 9 2008
Active Locations (1)
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1
Hospital Militar del General Luis Felipe Brieba Aran
Santiago, Reg. Metropolitana, Chile, 751-0021