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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06103734
Eligibility Criteria:
Inclusion Criteria:
1. Participants aged 18 years or older.
2. Participants with minimum 1 year history of migraine with age onset before 50 years of age.
Exclusion Criteria:
1. History of retinal migraine, basilar migraine or hemiplegic migraine.
2. History or current evidence of uncontrolled, unstable or recently diagnosed cardiovascular or cardiometabolic disease.
3. Major depressive disorder or anxiety disorder.
4. Acute or chronic pain syndromes.
5. Conditions that may affect the administration or absorption of the nasal product.
6. History of alcohol abuse and/or illicit drug.
7. Other social, medical, or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
8. Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s)
9. History of use of ergotamine medications or triptans on greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months. Or history of non-narcotic analgesic intake on greater than/equal to 15 days per month for greater than/equal to 3 months for other pain indications.
10. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days prior to Baseline Visit.
Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
11. Previous participation in any zavegepant study within the last 2 years.
12. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
1. Class 2 or Class 3 obesity, defined as body mass index \>35 kg/m2.
2. Estimated Globular Filtration Rate \<30 mL/min/1.73 m2.
3. Total bilirubin ≥1.5 × upper limit of normal.
4. Liver transaminases ≥2.0 × upper limit of normal .
5. Neutrophil count ≤1000/μL (or equivalent).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06103734
Study Brief:
Protocol Section:
NCT06103734