A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

763 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2002-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams\[mg\], 100mg, and 200mg taken daily) compared with placebo in the prevention of migraine.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the effectiveness and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily) in migraine prophylaxis. The study consists of five phases: baseline (determination of whether patients meet the eligibility criteria and tapering of any migraine medication patients are already taking); initial titration and double-blind phase (8 weeks) which begins with 25 mg/daily increasing to the assigned (50, 100, 200 mg/day topiramate); followed by a maintenance period at the target dose (18 weeks); tapering transition phase (up to 7 weeks); and open-label extension up to 6 months (to a maximum topiramate dose of 1600 mg/day); doses are adjusted to maximize effectiveness and minimize side effects. The primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase and that topiramate treatment is well tolerated. During the titration period (8 weeks), doses are increased to target dose of daily topiramate (50 milligrams\[mg\], 100, or 200mg) or placebo, taken twice daily by mouth. Doses are continued for 18 weeks, adjusted over 7 weeks, and continued for up to 6 months during the Open-Label Extension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Common Migraine Classic Migraine Headache

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Migraine Common Migraine Classic Migraine Headache Topiramate Prophylaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

topiramate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 6 months 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)

Exclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Role: STUDY_DIRECTOR

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

References

Explore related publications, articles, or registry entries linked to this study.

Silberstein SD, Neto W, Schmitt J, Jacobs D; MIGR-001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004 Apr;61(4):490-5. doi: 10.1001/archneur.61.4.490.

Reference Type RESULT

PMID: 15096395 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR002254

Identifier Type: -

Identifier Source: org_study_id