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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT02485418
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
* The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
* Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
* Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
* Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
* Patients age 7-18 years old
* Gender: both male and female
* Appropriate fasting interval as per ASA guidelines
Exclusion Criteria:
* No long acting triptan therapy within 24 hours
* No shorter acting triptan therapy within 6 hours
* No ergot alkaloid derivatives within the last 24 hours
* No opioid within 2 hours
* No NSAID or acetaminophen within 1 hour of infusion
* Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
* Headache not consistent with subject's headache history needing further work-up
* Headache duration less than 24 hours
* Subjects in which an intravenous line could not be secured
* Subjects with history of significant reflux or hiatal hernia
* Subjects with history of significant cardio pulmonary disorders
* Patient not fasting as per ASA guidelines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
18 Years
Study:
NCT02485418
Study Brief:
Protocol Section:
NCT02485418