NCT00236561

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of two doses of topiramate (100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The study will also assess dose response relationship of topiramate, estimate the relative efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect of migraine prevention with topiramate versus placebo on Health Related Quality of Life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
786

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2001

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

First QC Date

October 7, 2005

Last Update Submit

November 18, 2010

Conditions

MigraineCommon MigraineClassic MigraineHeadache

Keywords

MigraineCommon MigraineClassic MigraineHeadacheTopiramatePropranololProphylaxisPrevention

Outcome Measures

Primary Outcomes (1)

  • Change in the monthly (28 days) migraine period rate from the Prospective Baseline Period to the Core Double-Blind Phase.

Secondary Outcomes (1)

  • Proportion of patients responding to treatment.Change from Baseline Phase to Core Double-Blind Phase in number of monthly migraine attacks,monthly migraine days, number of days/month requiring rescue medication,and Health Related Quality of Life measures

Interventions

topiramate, propranololDRUG

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study
  • Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and non-migraine) per month during the Baseline Phase
  • No clinically significant abnormalities on neurological exams, electrocardiogram (ECG) or clinical laboratory test results at baseline
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

You may not qualify if:

  • Patients with headaches other than migraine
  • Patients with episodic tension or sinus headaches
  • Onset of migraine after age of 50 years
  • Patients who have failed more than two adequate regimens for migraine prophylaxis
  • Patients who overuse pain medications or certain other medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Diener HC, Tfelt-Hansen P, Dahlof C, Lainez MJ, Sandrini G, Wang SJ, Neto W, Vijapurkar U, Doyle A, Jacobs D; MIGR-003 Study Group. Topiramate in migraine prophylaxis--results from a placebo-controlled trial with propranolol as an active control. J Neurol. 2004 Aug;251(8):943-50. doi: 10.1007/s00415-004-0464-6.

    PMID: 15316798RESULT

MeSH Terms

Conditions

Migraine DisordersMigraine without AuraMigraine with AuraHeadache

Interventions

TopiramatePropranolol

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

April 1, 2001

Study Completion

December 1, 2002

Last Updated

November 19, 2010

Record last verified: 2010-11