A Study of RO4917523 in Patients With Fragile X Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01517698

Run by

Hoffmann-La Roche

People needed

185

Starts

2012-05-01

Expected to finish

2014-04-01

Last updated by the study team

2016-07-11

Who can join

Age: 14 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult and adolescent patients, 14-50 years of age
• Diagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1) full mutation and qualifying scores on the Aberrant Behavior Checklist (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

You may not qualify if…

• Previous treatment with another metabotropic glutamate (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

Where it is running

• Study site — Long Beach, California, United States
• Study site — Sacramento, 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 — New York, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Media, Pennsylvania, 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
• Study site — Bahía Blanca, Argentina
• Study site — Caba, Argentina
• Study site — Caba, Argentina
• Study site — Brampton, Ontario, Canada
• Study site — Sherbrooke, Quebec, Canada
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.