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Efficacy of Pregabalin in Migraine Prevention

Primary Purpose

Migraine Disorders

Status
Withdrawn
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Pregabalin
sodium valproate
Sponsored by
Hospital Militar del General Luis Felipe Brieba Aran
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring pregabalin, Valproic acid, migraine, prophylaxis, prevention, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Militar del General Luis Felipe Brieba Aran

Outcomes

Primary Outcome Measures

days with migraine

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2007
Last Updated
May 6, 2008
Sponsor
Hospital Militar del General Luis Felipe Brieba Aran
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1. Study Identification

Unique Protocol Identification Number
NCT00447369
Brief Title
Efficacy of Pregabalin in Migraine Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Because we did not find funds to do it
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Militar del General Luis Felipe Brieba Aran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
pregabalin, Valproic acid, migraine, prophylaxis, prevention, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
sodium valproate
Primary Outcome Measure Information:
Title
days with migraine
Secondary Outcome Measure Information:
Title
hours with migraine
Title
headache severity index
Title
level of disability
Title
reports of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norberto Bilbeny, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Militar del General Luis Felipe Brieba Aran
City
Santiago
State/Province
Reg. Metropolitana
ZIP/Postal Code
751-0021
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
11251695
Citation
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.
Results Reference
background
Links:
URL
http://www.i-h-s.org/
Description
International Headache Society

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Efficacy of Pregabalin in Migraine Prevention

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