Efficacy of Pregabalin in Migraine Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447369
Recruitment Status : Withdrawn (Because we did not find funds to do it)
First Posted : March 14, 2007
Last Update Posted : May 9, 2008
Information provided by:
Hospital Militar del General Luis Felipe Brieba Aran

March 13, 2007
March 14, 2007
May 9, 2008
May 2007
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days with migraine
Same as current
Complete list of historical versions of study NCT00447369 on Archive Site
  • hours with migraine
  • headache severity index
  • level of disability
  • reports of adverse events
Same as current
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Efficacy of Pregabalin in Migraine Prevention
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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.
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Migraine Disorders
  • Drug: Pregabalin
  • Drug: sodium valproate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2008
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Hospital Militar del General Luis Felipe Brieba Aran
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Principal Investigator: Norberto Bilbeny, MD
Hospital Militar del General Luis Felipe Brieba Aran
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP