A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome

• Conditions: Fragile X Syndrome (FXS); MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-004349-42-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-21
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

? Adults and adolescents (16 to 50)
? CGI-S of 3 (mildly ill) or more
? ABC total score of 20 or more
? Diagnosis of FXS with a confirmed FMR1 full mutation
Are the trial subjects under 18? yes
Number of subjects for this age range: 49
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 131
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Have previously received treatment with another mGlu5 receptor antagonist within 18 months or RO4917523
? Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 5 times the half-life (whichever is longer)
? Any uncontrolled, unstable clinically significant psychiatric condition other than FXS that may interfere with interpretation of safety and efficacy evaluations (e.g. Attention Deficit Hyperactivity Disorder (ADHD))
? Current symptoms or presumption of psychosis or euphoria, history of catatonia, hallucinations or delusional thoughts
? History of suicidal behaviour or otherwise considered a high suicidal risk by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified