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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00285402
Eligibility Criteria:
Primary Inclusion Criteria:
1. Has migraine headaches with or without aura according to International Headache Society guidelines (Committee, 2004).
2. Has had migraines for at least 6 months prior to study enrollment period.
3. Migraines began before age 50.
4. Has 2 to 10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 months prior to study enrollment.
5. Has 2 to 10 attacks in 30 days during the Baseline Period.
Additional inclusion criteria in protocol
Primary Exclusion Criteria:
1. Has headache equal to or greater than 18 days per month.
2. Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
3. Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine \[DHE\]) greater than 15 days per month.
4. Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
5. Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.
Additional exclusion criteria in protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT00285402
Study Brief:
Protocol Section:
NCT00285402