BP27832 - Study of RO5186582 in Downs Syndrome
Research type
Research Study
Full title
A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RO5186582 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME
IRAS ID
145517
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2013-001263-23
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
RO5186582 is an experimental medicine that we hope will improve memory and attention in people with Down's Syndrome by blocking sites in the brain called GABA(A)α5 receptors.
There has been limited success to date in treating cognitive symptoms in Down's syndrome and it remains a high unmet need. The purpose of this study is to investigate RO5186582 and its effect on cognition and behaviour. It is anticipated that benefit from RO5186582 will be greatest in younger individuals, therefore this study will enroll young adults as well as adolescents with Down's syndrome.
Adults and adolescents aged 12 to 30 years old will be invited to take part in this study which will run at hospital sites in England.
The study lasts for about 10 months and participants would attend 10 visits at the hospital site.
REC name
HSC REC B
REC reference
14/NI/0003
Date of REC Opinion
19 Mar 2014
REC opinion
Further Information Favourable Opinion