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 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT04726592
Eligibility Criteria:
Inclusion Criteria:
* Age from 18 to 70
* Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3)
* Present migraine attack lasting ≤ 72 hours
* Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe)
* Patient requiring parenteral treatment
* Affiliation to the French Health-care System "sécurité sociale"
Exclusion Criteria:
* abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg
* suspicion of secondary headache
* inability to understand the consent or scales
* pregnancy or breast-feeding
* known respiratory or liver insufficiency
* acute alcohol consumption or alcoholism
* myasthenia
* Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours
* recent use of benzodiazepines (\< 24h diazepam, clonazepam, clorazepate ; \< 6h alprazolam, lorazepam, midazolam)
* recent use of pain killers (\< 2h)
* contraindication to any of the investigational medication
* contraindication to intravenous access
* previous participation to this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04726592
Study Brief:
Protocol Section:
NCT04726592