NCT00447369

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

First QC Date

March 13, 2007

Last Update Submit

May 6, 2008

Conditions

Migraine Disorders

Keywords

pregabalinValproic acidmigraineprophylaxispreventiontreatment

Outcome Measures

Primary Outcomes (1)

  • days with migraine

Secondary Outcomes (4)

  • hours with migraine

  • headache severity index

  • level of disability

  • reports of adverse events

Interventions

PregabalinDRUG
sodium valproateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Militar del General Luis Felipe Brieba Aran

Santiago, Reg. Metropolitana, 751-0021, Chile

Location

Related 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. doi: 10.1046/j.1526-4610.2001.111006119.x.

    PMID: 11251695BACKGROUND

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

PregabalinValproic Acid

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsPentanoic AcidsValeratesFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Norberto Bilbeny, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 14, 2007

Study Start

May 1, 2007

Study Completion

March 1, 2008

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

CL(1)