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NCT00447369 Clinical Trial

Efficacy of Pregabalin in Migraine Prevention

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00447369
Other study ID # HM-PN-001
Secondary ID
Status Withdrawn
Phase Phase 3
First received March 13, 2007
Last updated May 6, 2008
Start date May 2007
Est. completion date March 2008

Study information
Verified date May 2008
Source Hospital Militar del General Luis Felipe Brieba Aran
Contact n/a
Is FDA regulated No
Health authority Chile: Instituto de Salud Pública de Chile
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 70
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

• sodium valproate

Locations
Country Name City State
Chile Hospital Militar del General Luis Felipe Brieba Aran Santiago Reg. Metropolitana

Sponsors (1)
Lead Sponsor Collaborator
Hospital Militar del General Luis Felipe Brieba Aran

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary days with migraine
Secondary hours with migraine
Secondary headache severity index
Secondary level of disability
Secondary reports of adverse events
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