Trial | NCT00447369  Report issue

Title

Efficacy of Pregabalin in Migraine Prevention

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    70
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.
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 Started
May 31
2007
Study Completion
Mar 31
2008
Anticipated
Last Update
May 09
2008
Estimate

Drug Pregabalin

Drug sodium valproate

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.
No Results Posted