The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine
January 31, 2011 updated by: Janssen Pharmaceutica N.V., Belgium
A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine
The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.
Study Overview
Detailed Description
Previous studies have shown that topiramate is effective in preventing chronic migraine headaches.
This study will start with a 4-week baseline period in which no treatment is given, followed by a 12-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase.
The individualized 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 who are randomized to receive topiramate will remain on the optimized dose.
The comparison phase of the study is a 16-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 from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group.
During the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of migraine for >= 1 year
- Headache type meets HIS (International Headache Society) criteria for migraine
- History reflects "chronic" headache--an average of >= 15 migraine days per month in the 3 months preceding trial entry
- History of chronic migraine for >=1 year>=15 headaches per month with an average duration of 4 hours if not treated
- Patient is otherwise neurologically and physically healthy on a pre-trial exam.
Exclusion Criteria:
- Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
- Onset of migraine after age 50
- Use of an anticonvulsant drug in the month prior to trial entry
- Use of an antidepressant unless dose has been used at a stable dose for >=3 months
- Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
- Use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Change in migraine days, migraine periods, and migraine attacks compared between the topiramate group and placebo group at the last month of the baseline phase and the last month of the placebo-controlled phase
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Health-related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, MSQ) over 16 double-blind weeks; Patient's satisfaction with the effectiveness and safety of topiramate; Safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 1, 2011
Last Update Submitted That Met QC Criteria
January 31, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003928
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.