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The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

CompletedPhase 3NCT00216606
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 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 details

Official title
A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine
Conditions
Interventions
Sponsor
Janssen Pharmaceutica N.V., Belgium
Start date
2003-12
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00216606