A Study of RO5186582 in Down Syndrome Among Children 6 to 11 Years of Age

Status:	Terminated
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	6 - 11
Updated:	4/1/2017
Start Date:	October 28, 2015
End Date:	August 3, 2016

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group 26-Week Dose-Investigating Study to Explore the Pharmacokinetics, Pharmacodynamic Effects, Efficacy, Safety and Tolerability of RO5186582 in Children With Down Syndrome Aged 6-11 Years

This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and
pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total
of approximately 46 participants will be enrolled, in order to have at least 32 evaluable,
and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per
treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately
1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.

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)

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000