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The Prolonged Use of Topiramate for Preventing Migraine Headaches

NCT00216619 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2014-07-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

Conditions

Interventions

DRUG

Topiramate

topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.

DRUG

Topiramate - Placebo

the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V. Clinical Trial · Janssen Pharmaceutica N.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2006-08-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Norway
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Slovenia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216619 on ClinicalTrials.gov