Efficacy of Pregabalin in Migraine Prevention

Hospital Militar del General Luis Felipe Brieba Aran

Status and phase

Withdrawn

Phase 3

Conditions

Migraine Disorders

Treatments

Drug: sodium valproate

Drug: Pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT00447369

HM-PN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.