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Fragile X study

Ongoing clinical trial
A Randomised, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients with Fragile X Syndrome.

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

Inclusion Criteria:
Adult and adolescent patients, 16-50 years of age, diagnosis of fragile X syndrome with a confirmed FMR1 full mutation and qualifying scores on the ABC and CGI-S.

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, or history of suicidal behaviour.

Primary Outcome Measures are changes in Anxiety Depression and Mood Scale (ADAMS) social avoidance factor, and safety (incidence of adverse events). Secondary Outcome Measures are changes in Aberrant Behavior Checklist, Anxiety Depression and Mood Scale (ADAMS), Clinical Global Impressions Scale - Improvement (CGI-I), Clinical Global Impressions Scale – Severity (CGI-S), and Clinical Response (at least 25% improvement in the Aberrant Behavior Checklist and a CGI-I score of 1 or 2).

ClinicalTrials.gov: NCT01517698

Page Manager: Anna Spyrou|Last update: 12/25/2012

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