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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02764320
Eligibility Criteria:
Inclusion Criteria
* Adults, at least 21 years of age
* Chronic Migraine - diagnosed according to ICHD3beta criteria
* Medication Overuse - diagnosed according to ICHD3beta criteria
* Willingness to be randomized to either of the two treatment arms
* Willingness to maintain a headache diary
* Plan for follow-up care with the clinician
* No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
Exclusion Criteria
* Younger than 21 years of age
* Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
* Not willing to be randomized to either of the treatment arms
* Not willing to maintain a daily headache diary
* Not planning on follow-up care with the clinician
* In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
* Prisoners
* Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02764320
Study Brief:
Protocol Section:
NCT02764320