Pregabalin and Valproic Acid and sodium valproate in Migraine Disorders - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Migraine Disorders

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Chile
- Reg. Metropolitana
  - Santiago, Reg. Metropolitana, Chile, 751-0021
    - Hospital Militar del General Luis Felipe Brieba Aran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
days with migraine

Secondary Outcome Measures

Outcome Measure
hours with migraine
headache severity index
level of disability
reports of adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Militar del General Luis Felipe Brieba Aran

Investigators

Principal Investigator: Norberto Bilbeny, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, Stacey B, Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001 Feb;41(2):119-28. doi: 10.1046/j.1526-4610.2001.111006119.x.

Helpful Links

International Headache Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria