Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
6–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
