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A Study of RO4917523 in Patients With Fragile X Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01517698
First received: January 20, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and ad ult patients with fragile X syndrome. Patients will be randomized to receive ora l doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The an ticipated time on study treatment is 12 weeks.


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


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 185
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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:   14 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517698

  Show 51 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: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014