Efficacy of Pregabalin in Migraine Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pregabalin

Intervention Type DRUG

sodium valproate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No