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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

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Recruiting
Long Beach, California, United States, 90806
Recruiting
Sacramento, California, United States, 95817
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20010
United States, Georgia
Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Not yet recruiting
Indianapolis, Indiana, United States, 46202-5225
United States, Iowa
Recruiting
Iowa City, Iowa, United States, 52242-1083
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Recruiting
Worcester, Massachusetts, United States, 01655
United States, New York
Recruiting
New York, New York, United States, 10029
Recruiting
Staten Island, New York, United States, 10314
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Recruiting
Media, Pennsylvania, United States, 19063
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37232-7548
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Recruiting
San Antonio, Texas, United States, 78258
United States, Washington
Recruiting
Seattle, Washington, United States, 98145
Argentina
Not yet recruiting
Bahia Blanca, Argentina, 8000
Recruiting
Buenos Aires, Argentina, C1425CDC
Not yet recruiting
Caba, Argentina, 1425
Recruiting
Caba, Argentina, 1425
Canada, Ontario
Recruiting
Brampton, Ontario, Canada, L6Y 1M5
Chile
Not yet recruiting
Santiago, Chile, 833033
Not yet recruiting
Santiago, Chile
Recruiting
Santiago, Chile
Recruiting
Valparaiso, Chile, 2340000
France
Recruiting
Bordeaux, France, 33076
Active, not recruiting
Bron, France, 69003
Recruiting
Dijon, France, 21079
Recruiting
Marseille, France, 13385
Recruiting
Montpellier, France, 34295
Recruiting
Tours, France, 37044
Mexico
Not yet recruiting
Aguascalientes, Mexico, 20030
Not yet recruiting
Mexico, Mexico, 04530
Not yet recruiting
Zapopan, Mexico, 45129
Peru
Not yet recruiting
Lima, Peru
Not yet recruiting
Lima, Peru, Lima 14
Recruiting
Lima, Peru, Lima 33
Spain
Recruiting
El Palmar. Murcia, Spain, 30120
Recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28046
Recruiting
San Cugat Del Valles, Spain, 08195
Recruiting
San Sebastian, Spain, 20009
Recruiting
Torremolinos, Spain, 29620
Sweden
Recruiting
Gothenburg, Sweden, 411 19
United Kingdom
Recruiting
Belfast, United Kingdom, BT12 6AB
Recruiting
Dundee, United Kingdom, DD1 9SY
Recruiting
Edinburgh, United Kingdom, EH10 5HF
Recruiting
Glasgow, United Kingdom, GS 8SJ
Recruiting
London, United Kingdom, W1W 7EJ
Recruiting
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: 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 June 18, 2013