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Efficacy of Pregabalin in Migraine Prevention

This study has been withdrawn prior to enrollment.
(Because we did not find funds to do it)
Information provided by:
Hospital Militar del General Luis Felipe Brieba Aran Identifier:
First received: March 13, 2007
Last updated: May 6, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Migraine Disorders
Drug: Pregabalin
Drug: sodium valproate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hospital Militar del General Luis Felipe Brieba Aran:

Primary Outcome Measures:
  • days with migraine

Secondary Outcome Measures:
  • hours with migraine
  • headache severity index
  • level of disability
  • reports of adverse events

Estimated Enrollment: 70
Study Start Date: May 2007
Estimated Study Completion Date: March 2008
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00447369

Hospital Militar del General Luis Felipe Brieba Aran
Santiago, Reg. Metropolitana, Chile, 751-0021
Sponsors and Collaborators
Hospital Militar del General Luis Felipe Brieba Aran
Principal Investigator: Norberto Bilbeny, MD
  More Information

Publications: Identifier: NCT00447369     History of Changes
Other Study ID Numbers: HM-PN-001
Study First Received: March 13, 2007
Last Updated: May 6, 2008

Keywords provided by Hospital Militar del General Luis Felipe Brieba Aran:
Valproic acid

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Anti-Anxiety Agents processed this record on May 25, 2017