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A Study of RO4917523 in Patients With Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT01517698
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 20, 2012
First Posted Date  ICMJE January 25, 2012
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Change in Anxiety Depression and Mood Scale (ADAMS) total score [ Time Frame: 12 weeks ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Change in Anxiety Depression and Mood Scale (ADAMS) social avoidance factor [ Time Frame: 12 weeks ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01517698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Change in Social Responsiveness Scale (SRS) [ Time Frame: 12 weeks ]
  • Change in Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: 12 weeks ]
  • Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) [ Time Frame: 12 weeks ]
  • Change in Aberrant Behavior Checklist total score [ Time Frame: 12 weeks ]
  • Change in Aberrant Behavior Checklist factor scores [ Time Frame: 12 weeks ]
  • Change in Anxiety Depression and Mood Scale (ADAMS) factor scores [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Change in Aberrant Behavior Checklist [ Time Frame: 12 weeks ]
  • Change in Anxiety Depression and Mood Scale (ADAMS) [ Time Frame: 12 weeks ]
  • Change in Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: 12 weeks ]
  • Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S) [ Time Frame: 12 weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RO4917523 in Patients With Fragile X Syndrome
Official Title  ICMJE A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fragile X Syndrome
Intervention  ICMJE
  • Drug: Placebo
    placebo to RO4917523 orally once a day for 12 weeks
  • Drug: RO4917523 0.5 mg
    0.5 mg orally once a day for 12 weeks
  • Drug: RO4917523 1.5 mg
    1.5 mg orally once a day for 12 weeks
Study Arms  ICMJE
  • Experimental: RO4917523 0.5 mg
    Intervention: Drug: RO4917523 0.5 mg
  • Experimental: RO4917523 1.5 mg
    Intervention: Drug: RO4917523 1.5 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
185
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2012)
180
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   France,   Mexico,   Peru,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01517698
Other Study ID Numbers  ICMJE NP27936
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2016

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