Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT00210535
Eligibility Criteria:
Inclusion Criteria:
* History of migraine (with or without aura) conforming to International Headache Society (IHS) criteria for pediatric subjects for \>=6 months prior to screening
* Requires migraine prophylactic therapy, and if previously treated to prevent attacks, had unsatisfactory response to therapy
* Experienced an average of 3 to 12 migraine attacks and no more than 14 headache days per month during the 3 months prior to the study
* Females must be sexually abstinent, surgically sterile, or using adequate contraceptive measures, and have negative pregnancy tests before and during the study
Exclusion Criteria:
* Currently taking or previously unable to tolerate topiramate, or previously failed therapy with topiramate for migraine prophylaxis
* Has mixed headaches and is unable to distinguish migraines from other headache types
* Overuses pain medications or specific agents for abortive treatment of migraine attacks
* Has a body mass index (BMI) greater than 40 or weighs more than 200 pounds, or is markedly underweight (below 5th percentile) for his or her age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT00210535
Study Brief:
Protocol Section:
NCT00210535