MedDataX Logo

Efficacy of Pregabalin in Migraine Prevention

NCT ID: NCT00447369

Last Updated: 2008-05-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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WITHDRAWN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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pregabalin Valproic acid migraine prophylaxis prevention treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregabalin

Intervention Type DRUG

sodium valproate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Militar del General Luis Felipe Brieba Aran

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Norberto Bilbeny, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Militar del General Luis Felipe Brieba Aran

Santiago, Reg. Metropolitana, Chile

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11251695 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.i-h-s.org/

International Headache Society

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM-PN-001

Identifier Type: -

Identifier Source: org_study_id