A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01750957

Run by

Hoffmann-La Roche

People needed

47

Starts

2013-02-01

Expected to finish

2014-04-01

Last updated by the study team

2016-08-11

Who can join

Age: 5 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents, 5 to 13 years of age
• Diagnosis of fragile X syndrome based on prior DNA testing confirming Fragile X Mental Retardation 1 (FMR1) full mutation and qualifying scores on the ABC and CGI-S

You may not qualify if…

• 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

Where it is running

• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Media, Pennsylvania, United States
• Study site — Greenwood, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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