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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447369
First Posted: March 14, 2007
Last Update Posted: May 9, 2008
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.
Information provided by:
Hospital Militar del General Luis Felipe Brieba Aran
  Purpose
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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447369


Locations
Chile
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
Investigators
Principal Investigator: Norberto Bilbeny, MD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00447369     History of Changes
Other Study ID Numbers: HM-PN-001
First Submitted: March 13, 2007
First Posted: March 14, 2007
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Hospital Militar del General Luis Felipe Brieba Aran:
pregabalin
Valproic acid
migraine
prophylaxis
prevention
treatment

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