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

Use our guide to learn which trials are right for you!

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
20
sites
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Greenwood, South Carolina 29646
?
mi
from
Greenwood, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Media, PA
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Worcester, MA
Click here to add this to my saved trials