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The Prolonged Use of Topiramate for Preventing Migraine Headaches
This study has been completed.
First Received: September 13, 2005   Last Updated: August 10, 2009   History of Changes
Sponsor: Janssen Pharmaceutica N.V., Belgium
Information provided by: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT00216619
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Topiramate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Change in migraine days compared between the topiramate group and placebo group at the last 4 weeks of the open-label phase and the final 4 weeks of the placebo-controlled phase

Secondary Outcome Measures:
  • Health related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, SF-12); safety and tolerability measures

Enrollment: 834
Study Start Date: November 2003
Study Completion Date: August 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Previous studies have shown that topiramate is effective in preventing migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. The dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients randomized to receive topiramate will remain on that dose. The comparison phase of the study is a 26-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of migraine for >= 1 year
  • migraine meets HIS (International Headache Society) criteria
  • average of >= 4 migraine days per month in the 3 months preceding trial entry
  • ability to keep trial records Exclusion Criteria:
  • Use of migraine prevention medicine in the month prior to trial entry (use of flunarizine in the 3 months prior to entry)
  • migraine was not relieved by >2 adequate prior regimens of migraine prevention medicines
  • use of disallowed concomitant therapy
  • overuse of analgesics, opioids, ergots and/or triptans
  • regular use of topiramate for >2 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216619

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided

Study ID Numbers: CR003931
Study First Received: September 13, 2005
Last Updated: August 10, 2009
ClinicalTrials.gov Identifier: NCT00216619     History of Changes
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
chronic migraine
Topiramate
migraine
headache
chronic headache

Additional relevant MeSH terms:
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Headache Disorders
Anti-Obesity Agents
Migraine Disorders
Therapeutic Uses
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 25, 2009