A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
1 other identifier
interventional
328
0 countries
N/A
Brief Summary
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedJune 10, 2011
April 1, 2010
September 13, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the average number of days per month with migraine or migrainous headache by daily headache record.
Secondary Outcomes (1)
Absolute change and % change from baseline in the headache index; change in the average daily and worst daily headache severity; quality of life assessments (MIDAS, MSQ, Physician's/Subject's global assessments of change.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic migraine
- \>=15 headache days per month in past 30 days
- \>= 15 headache days, half of which need to be migraine headaches during the prospective baseline period
- MIDAS test score \>= 11 at Visit 1
- In generally good health
- If female, using birth control
- No abnormalities on neurological examination
You may not qualify if:
- Failed \> 2 adequate trials of migraine prevention medications
- Failed topiramate due to lack of effectiveness or adverse events
- Daily headaches of severe intensity during past 30 days
- Cluster, basilar, ophthalmoplegic, or hemiplegic migraines
- Migraines started after age 50
- Other pain greater than migraine pain
- Use of drugs to treat migraines for \> 4 days per week during the past month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.
PMID: 17300356RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
September 1, 2003
Study Completion
April 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-04