A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
CompletedPhase 3NCT00210912
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
- Conditions
- Interventions
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Start date
- 2003-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00210912