Efficacy of Pregabalin in Migraine Prevention - Full Text View

Sponsored by:	Hospital Militar del General Luis Felipe Brieba Aran
Information provided by:	Hospital Militar del General Luis Felipe Brieba Aran
ClinicalTrials.gov Identifier:	NCT00447369

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 III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447369

Locations

Chile, Reg. Metropolitana
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

Unaffiliated

More Information

International Headache Society This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	HM-PN-001
Study First Received:	March 13, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00447369
Health Authority:	Chile: Instituto de Salud Publica de Chile

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

pregabalin
Valproic acid
migraine

prophylaxis
prevention
treatment

Study placed in the following topic categories:

Migraine Disorders
Headache
Pregabalin
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Valproic Acid
Headache Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents

Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
GABA Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009