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A Study of RO4917523 in Patients With Fragile X Syndrome

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01517698
First received: January 20, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Fragile X Syndrome
 Drug: RO4917523
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4917523
0.5 mg orally once a day for 12 weeks
Experimental: 2 Drug: RO4917523
1.5 mg orally once a day for 12 weeks
Placebo Comparator: 3 Drug: Placebo
placebo to RO4917523 orally once a day for 12 weeks

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult and adolescent patients, 16-50 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517698

Contacts
Contact: Please reference Study ID Number: NP27936 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01517698     History of Changes
Other Study ID Numbers: NP27936
Study First Received: January 20, 2012
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on May 19, 2013