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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517698
Other study ID # NP27936
Secondary ID
Status Completed
Phase Phase 2
First received January 20, 2012
Last updated July 6, 2016
Start date May 2012
Est. completion date April 2014

Study information

Verified date July 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
placebo to RO4917523 orally once a day for 12 weeks
RO4917523 0.5 mg
0.5 mg orally once a day for 12 weeks
RO4917523 1.5 mg
1.5 mg orally once a day for 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  France,  Mexico,  Peru,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Anxiety Depression and Mood Scale (ADAMS) total score 12 weeks No
Primary Safety (incidence of adverse events) 12 weeks No
Secondary Change in Social Responsiveness Scale (SRS) 12 weeks No
Secondary Change in Clinical Global Impressions Scale - Improvement (CGI-I) 12 weeks No
Secondary Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) 12 weeks No
Secondary Change in Aberrant Behavior Checklist total score 12 weeks No
Secondary Change in Aberrant Behavior Checklist factor scores 12 weeks No
Secondary Change in Anxiety Depression and Mood Scale (ADAMS) factor scores 12 weeks No
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