A Study of RO4917523 in Patients With Fragile X Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01517698
First received: January 20, 2012
Last updated: April 7, 2014
Last verified: April 2014

January 20, 2012
April 7, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
  • Change in Anxiety Depression and Mood Scale (ADAMS) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Depression and Mood Scale (ADAMS) social avoidance factor [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01517698 on ClinicalTrials.gov Archive Site
  • Change in Social Responsiveness Scale (SRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Aberrant Behavior Checklist total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Aberrant Behavior Checklist factor scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Depression and Mood Scale (ADAMS) factor scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Aberrant Behavior Checklist [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Anxiety Depression and Mood Scale (ADAMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Response (at least 25% improvement in the Aberrant Behavior Checklist and a Clinical Global Impressions Scale - Improvement score of 1 or 2) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RO4917523 in Patients With Fragile X Syndrome
A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fragile X Syndrome
  • Drug: RO4917523
    0.5 mg orally once a day for 12 weeks
  • Drug: RO4917523
    1.5 mg orally once a day for 12 weeks
  • Drug: Placebo
    placebo to RO4917523 orally once a day for 12 weeks
  • Experimental: 1
    Intervention: Drug: RO4917523
  • Experimental: 2
    Intervention: Drug: RO4917523
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
185
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult and adolescent patients, 14-50 years of age
  • Diagnosis of fragile X syndrome with a confirmed FMR1 full mutation and qualifying scores on the 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 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
Both
14 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Chile,   France,   Mexico,   Peru,   Spain,   Sweden,   United Kingdom
 
NCT01517698
NP27936
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP