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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT04232605
Eligibility Criteria:
Criteria for the healthy volunteers group
Inclusion Criteria:
* Healthy men/women.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.
Exclusion Criteria:
* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.
Criteria for the migraine patients group
Inclusion Criteria:
* Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.
Exclusion Criteria:
* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04232605
Study Brief:
Protocol Section:
NCT04232605