Efficacy of Pregabalin in Migraine Prevention | NCT00447369

Studies
Efficacy of Pregabalin in Migraine Prevention

NCT00447369

Sponsor

Hospital Militar del General Luis Felipe Brieba Aran

Status

Withdrawn

Last Update Posted

May 9, 2008Estimated

Enrollment

70Estimated

Phase

Phase 3

Conditions

Migraine Disorders

Interventions

Pregabalin
sodium valproate

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Because we did not find funds to do it

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Mar 13, 2007

First Submission Date that Met QC Criteria

Mar 13, 2007

First Posted Date

Mar 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2008

Last Update Posted Date

May 9, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Measure	Description	Time Frame
days with migraine

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norberto Bilbeny, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Militar del General Luis Felipe Brieba Aran		Santiago	Reg. Metropolitana	751-0021	Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11251695	Background	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. doi: 10.1046/j.1526-4610.2001.111006119.x.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D000069583	Pregabalin
D014635	Valproic Acid

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Measure	Description	Time Frame
hours with migraine
headache severity index
level of disability