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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT06959004
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 65 years of age upon entry into screening
* A body weight of 50 to 100 kg
* History of migraine without aura for ≥12 months and in accordance with ICHD-3
* Between 1-5 monthly migraine days without aura on average across the 3 months prior to screening
Exclusion Criteria:
* Any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache
* Any history of moderate to severe traumatic brain injury
* Any history of cardiovascular disease, including cerebrovascular diseases
* Any history of pulmonary disease
* Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Daily use of any medication other than contraceptives
* Intake of any medication other than contraceptives within 48 hours of infusion start
* Headache of any intensity within 48 hours of infusion start
* Migraine attack within 5 days of infusion start
* Aura within 48 hours of infusion start
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06959004
Study Brief:
Protocol Section:
NCT06959004