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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT03697161
Eligibility Criteria:
Inclusion Criteria:
* Is male and 13 to 22 years old (inclusive) at the time of informed consent.
* Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).
Exclusion Criteria:
* Concomitant disease or condition that are clinically significant and would limit study participation
* Clinically significant lab abnormalities or vital signs at the time of screening
* History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
* Unable or does not have a caregiver able to comply with study requirements.
* Enrolled in any clinical trial within the 30 days before screening.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
13 Years
Maximum Age:
22 Years
Study:
NCT03697161
Study Brief:
Protocol Section:
NCT03697161