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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06423794
Eligibility Criteria:
Key Inclusion Criteria:
1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.
Key Exclusion Criteria:
1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
3. Investigator deems subject at imminent risk of danger to others or themself.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06423794
Study Brief:
Protocol Section:
NCT06423794