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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT02484703

Run by

Hoffmann-La Roche

People needed

45

Starts

2015-10-28

Expected to finish

2016-08-03

Last updated by the study team

2017-07-06

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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)

Where it is running

• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• Emory University School of Medicine; Department of Human Genetics & Pediatrics — Decatur, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Massachusette General Hospital; Medical Genetics — Boston, Massachusetts, United States
• Boston Children's Hospital, Department of Neurology — Boston, Massachusetts, United States
• Duke Clin Rsch Institute — Durham, North Carolina, United States
• UPMC Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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