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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT00440518
Eligibility Criteria:
Inclusion Criteria:
* History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.
* Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.
* On effective stable abortive medication(s) for the acute treatment of migraine.
Exclusion Criteria:
* Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.
* Use of triptans or ergots for migraine abortive treatment \> 2-3 days per calendar week 2 months prior to screening.
* Experience 15 or more headache days per month of any kind 2 months prior to screening.
* Has another consistent or chronic form of headache.
* Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.
* Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.
* Significant laboratory or electrocardiograms (ECG) abnormalities
* Significant medical history including cardiovascular abnormalities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00440518
Study Brief:
Protocol Section:
NCT00440518