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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00261469
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry
* must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month
* must have failed \<=2 previous prophylactic medications due to lack of effectiveness
* must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)
* female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.
Exclusion Criteria:
* Subjects with headaches other than migraine with and/or without aura
* onset of migraine after age 50
* overuse analgesics or specific medications for treatment of migraine attacks
* currently on a prophylactic medication for migraine
* history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00261469
Study Brief:
Protocol Section:
NCT00261469