A Study of RO4917523 in Patients With Fragile X Syndrome

Status:	Completed
Conditions:	Other Indications
Therapuetic Areas:	Other
Healthy:	No
Age Range:	14 - 50
Updated:	4/21/2016
Start Date:	May 2012
End Date:	April 2014

A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will
investigate the efficacy and safety of RO4917523 in adolescent and adult patients with
fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of
RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12
weeks.

Inclusion Criteria:

- Adult and adolescent patients, 14-50 years of age

- Diagnosis of fragile X syndrome with a confirmed FMR1 full mutation and qualifying
scores on the ABC and CGI-S

- Patients must agree to either remain completely abstinent or to use two effective
contraceptive methods during and 3 weeks after the study

Exclusion Criteria:

- Previous treatment with another mGLU receptor antagonist within 18 months or with
RO4917523

- Participation in a clinical trial involving an investigational (unapproved) drug
within 3 months or 5 times the half-life (whichever is longer) before start of this
study

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

- History of suicidal behavior

We found this trial at

sites

Clinical Trial Facility in New York New York

New York, New York 10032

from

New York, NY