Efficacy of Pregabalin in Migraine Prevention

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447369

Enrollment

Registered

2007-03-14

Start date

2007-05-31

Completion date

2008-03-31

Last updated

2008-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Keywords

pregabalin, Valproic acid, migraine, prophylaxis, prevention, treatment

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.

Interventions

DRUGPregabalin

DRUGsodium valproate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
days with migraine	—

Secondary

Measure	Time frame
hours with migraine	—
headache severity index	—
level of disability	—
reports of adverse events	—

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026