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: July 14, 2014
Last verified: July 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: 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:


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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Long Beach, California, United States, 90806
Sacramento, California, United States, 95817
United States, Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa City, Iowa, United States, 52242-1083
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, New York
New York, New York, United States, 10029
Staten Island, New York, United States, 10314
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Media, Pennsylvania, United States, 19063
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78258
United States, Washington
Seattle, Washington, United States, 98145
Argentina
Bahia Blanca, Argentina, 8000
Caba, Argentina, 1425
Caba, Argentina, C1126AAB
Canada, Ontario
Brampton, Ontario, Canada, L6Y 1M5
Canada, Quebec
Sherbrooke, Quebec, Canada, J1H 5N4
Chile
Santiago, Chile
Valparaiso, Chile, 2340000
France
Bordeaux, France, 33076
Bron, France, 69003
Dijon, France, 21079
Marseille, France, 13385
Montpellier, France, 34295
Paris, France, 75013
Tours, France, 37044
Mexico
Aguascalientes, Mexico, 20030
Mexico, Mexico, 04530
Peru
Lima, Peru, Lima 33
Lima, Peru
Spain
San Cugat del Valles, Barcelona, Spain, 08195
San Sebastian, Guipuzcoa, Spain, 20009
Torremolinos, Malaga, Spain, 29620
El Palmar. Murcia, Murcia, Spain, 30120
Madrid, Spain, 28040
Madrid, Spain, 28046
Sweden
Gothenburg, Sweden, 411 19
United Kingdom
Belfast, United Kingdom, BT12 6AB
Dundee, United Kingdom, DD1 9SY
Edinburgh, United Kingdom, EH10 5HF
Glasgow, United Kingdom, GS 8SJ
London, United Kingdom, W1W 7EJ
Manchester, United Kingdom, M13 9WL
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: July 14, 2014
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 July 20, 2014