A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

Hoffmann-La Roche0 sites185 target enrollmentMay 2012

ConditionsFragile X Syndrome

InterventionsRO4917523 0.5 mg RO4917523 1.5 mg Placebo

DrugsPlacebo RO4917523 0.5 mg RO4917523 1.5 mg

Overview

Phase: Phase 2
Intervention: RO4917523 0.5 mg
Conditions: Fragile X Syndrome
Sponsor: Hoffmann-La Roche
Enrollment: 185
Primary Endpoint: Change in Anxiety Depression and Mood Scale (ADAMS) total score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

April 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

RO4917523 0.5 mg

Intervention: RO4917523 0.5 mg

RO4917523 1.5 mg

Intervention: RO4917523 1.5 mg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Anxiety Depression and Mood Scale (ADAMS) total score

Time Frame: 12 weeks

Safety (incidence of adverse events)

Time Frame: 12 weeks

Secondary Outcomes

Change in Social Responsiveness Scale (SRS)(12 weeks)
Change in Clinical Global Impressions Scale - Improvement (CGI-I)(12 weeks)
Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S)(12 weeks)
Change in Aberrant Behavior Checklist total score(12 weeks)
Change in Aberrant Behavior Checklist factor scores(12 weeks)
Change in Anxiety Depression and Mood Scale (ADAMS) factor scores(12 weeks)