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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT02484703
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Down syndrome, except for mosaic Down syndrome
* Available parent or caregiver to attend clinic visits and provide information about the participant's behavior and symptoms
Exclusion Criteria:
* Any primary psychiatric comorbid disorder
* History of infantile spasms, West syndrome, Lennox-Gastaut syndrome, early infantile epileptic encephalopathy, treatment-refractory epilepsy with cognitive/developmental regression, severe head trauma, or central nervous system (CNS) infection
* Seizure event of any type within 12 months prior to Screening or relevant changes in anti-epileptic drugs 6 weeks prior to enrollment
* Significant sleep disruption
* Significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular disease
* New-onset or ongoing hematologic/oncologic disorder
* Severe lactose intolerance
* Participation in another clinical study within 1 month or 6 half-lives prior to first dose, or any extent of participation in Study BP29589 (NCT02451657)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT02484703
Study Brief:
Protocol Section:
NCT02484703