Status:
COMPLETED
A Study of RO4917523 in Patients With Fragile X Syndrome
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
14-50 years
Phase:
PHASE2
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. Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01517698
Start Date
May 1 2012
End Date
April 1 2014
Last Update
July 11 2016
Active Locations (51)
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1
Phoenix, Arizona, United States, 85006
2
Long Beach, California, United States, 90806
3
Sacramento, California, United States, 95817
4
Aurora, Colorado, United States, 80045