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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04106557
Eligibility Criteria:
Inclusion Criteria:
* Male or female and 2 to 12 years old (inclusive) at the time of informed consent
* Confirmed molecular diagnosis of AS
* Has a CGI-S-AS score of 3 or more at baseline.
* Meets the following age-appropriate body weight criterion:
1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).
* Stable concomitant mediations for at least 4 weeks before study start
Exclusion Criteria:
* Any condition that would limit study participation
* Clinically significant lab or vital sign abnormalities at the time of screening
* Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)
* Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.
* Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.
* Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT04106557
Study Brief:
Protocol Section:
NCT04106557