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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01044251
Eligibility Criteria:
Inclusion Criteria:
* MOH diagnosed by IHS criteria
* Diagnosis of migraine (with or without aura) in past by IHS criteria
* If patients do not have a baseline diary, then a prospective diary for a 10-day period will be done to confirm medication overuse before study entry.
* Patients aged 18 to 65 years.
* Normal neurological examination.
* Patient is willing and able (in terms of capacity) to sign informed consent.
* Patient is able to understand and complete study protocol, including completion of headache diaries.
* Patient has a stable medical condition.
Exclusion Criteria:
* Headache not meeting IHS criteria for MOH.
* Presence of hemiplegic, basilar, ophthalmoplegic migraine or migrainous infarction.
* Findings on history, neurological exam, or neuroimaging suggestive of secondary causes of headache.
* Post-whiplash or post-traumatic headaches.
* Contraindications to triptans (such as heart disease, peripheral vascular disease or uncontrolled hypertension) or previous serious side effects/intolerance.
* Major psychiatric conditions (such as major depression, bipolar disorder, schizophrenia, addiction), either diagnosed by a physician or positive on standard clinic assessment tools (e.g. BDI questionnaire).
* Major medical conditions or treatments that may interfere with the patient's ability to participate in the study, such as dementia, advanced or terminal cancer, chemotherapy, etc.
* Patient is pregnant, breastfeeding, or is expecting to conceive within the time period of the study. Pregnancy will be determined using a urine test.
* Women of childbearing potential who are not using a reliable method of contraception.
* Patient is a recent user of illicit/recreational drugs or plans to use illicit drugs during the study time period.
* Patient has a recent history of alcohol abuse or dependence, or plans to abuse alcohol during the study duration.
* Patient is unlikely to comply with the study protocol, keep diaries and appointments, or does not have a fixed telephone or address.
* Patient is enrolled in another study or trial that may interfere with their participation or the results of this study.
* Patients with greater than 30% of their data missing during the ten days of baseline diary data collection.
* Patients with mean headache intensities of less than 3 (from a pain scale of 0 to 10, where 0=no pain and 10=pain as bad as possible) during the 10-day baseline period.
* Patients with ongoing Botox treatments or those who have received Botox in the last 4 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01044251
Study Brief:
Protocol Section:
NCT01044251