Efficacy of Pregabalin in Migraine Prevention
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
- days with migraine
- 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 |
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 |
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| Chile | |
| Hospital Militar del General Luis Felipe Brieba Aran | |
| Santiago, Reg. Metropolitana, Chile, 751-0021 | |
| Principal Investigator: | Norberto Bilbeny, MD |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00447369 History of Changes |
| Other Study ID Numbers: | HM-PN-001 |
| Study First Received: | March 13, 2007 |
| Last Updated: | May 6, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pregabalin Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
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 Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013