A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Status:	Completed
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	5 - 13
Updated:	8/3/2016
Start Date:	February 2013
End Date:	February 2014

A RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, SAFETY AND EXPLORATORY EFFICACY AND PHARMACOKINETIC, STUDY OF RO4917523 IN PEDIATRIC PATIENTS WITH FRAGILE X SYNDROME

This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the
safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with
fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523
or placebo orally daily for 12 weeks.

Inclusion Criteria:

- Children and adolescents, 5 to 13 years of age

- Diagnosis of fragile X syndrome based on prior DNA testing confirming FMR1 full
mutation and qualifying scores on the ABC and CGI-S

Exclusion Criteria:

- Previous treatment with another mGlu5 receptor antagonist within the prior 3 months

- Participation in a clinical trial involving an investigational drug (unapproved) or
non-drug treatment within the prior 6 weeks or 5 times the half-life (whichever is
longer) before the start of this study

- Any uncontrolled, unstable clinically significant psychiatric condition other than
fragile X syndrome

- History of suicidal behavior

- Other protocol defined inclusion/exclusion criteria may apply

We found this trial at

sites

Clinical Trial Facility in Aurora Colorado

Aurora, Colorado 80045

1154

from 43215

Aurora, CO