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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00231595
Other study ID # CR003208
Secondary ID
Status Completed
Phase Phase 3
First received September 30, 2005
Last updated November 18, 2010
Start date March 2001
Est. completion date November 2002

Study information

Verified date November 2010
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams[mg], 100mg, and 200mg per day) compared with placebo in the prevention of migraine. The study will also assess the dose response relationship and the efficacy of treatment with topiramate versus placebo on Health-Related Quality of Life.


Description:

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy 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), Double-Blind (patients receive either 50 milligrams[mg], 100mg, 200mg of topiramate, or placebo), Blinded Transition Phase (doses of study medication are adjusted over 7 weeks in preparation for the Open-Label Extension Phase), Open-Label Extension Phase (patients continue the study medication in open-label manner for up to 6 months; doses are adjusted to maximize effectiveness and minimize side effects), Taper/Exit Phase (study medication is slowly discontinued over 2 weeks). 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. Topiramate tablets (50milligrams [mg], 100mg, 200mg, or placebo) taken by mouth as twice-daily regimen during the 26-week Double-Blind Phase. Doses are adjusted and continued during the 6 month Open-Label Extension Phase after which they are tapered over 2 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 768
Est. completion date November 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 65 Years
Eligibility 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

Study Design

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


Intervention

Drug:
topiramate


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References & Publications (1)

Brandes JL, Saper JR, Diamond M, Couch JR, Lewis DW, Schmitt J, Neto W, Schwabe S, Jacobs D; MIGR-002 Study Group. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004 Feb 25;291(8):965-73. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase.
Secondary Proportion of patients responding to the treatment. Changes from baseline to the 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
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