A Study of RO4917523 in Patients With Fragile X Syndrome
A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.
1 other identifier
interventional
185
10 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJuly 11, 2016
July 1, 2016
1.9 years
January 20, 2012
July 6, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Anxiety Depression and Mood Scale (ADAMS) total score
12 weeks
Safety (incidence of adverse events)
12 weeks
Secondary Outcomes (6)
Change in Social Responsiveness Scale (SRS)
12 weeks
Change in Clinical Global Impressions Scale - Improvement (CGI-I)
12 weeks
Change in Clinical Global Impressions Scale - Severity of Illness (CGI-S)
12 weeks
Change in Aberrant Behavior Checklist total score
12 weeks
Change in Aberrant Behavior Checklist factor scores
12 weeks
- +1 more secondary outcomes
Study Arms (3)
RO4917523 0.5 mg
EXPERIMENTALRO4917523 1.5 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Iowa City, Iowa, 52242-1083, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Staten Island, New York, 10314, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45229, United States
Unknown Facility
Media, Pennsylvania, 19063, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78258, United States
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Seattle, Washington, 98145, United States
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Bahía Blanca, 8000, Argentina
Unknown Facility
Caba, 1425, Argentina
Unknown Facility
Caba, C1126AAB, Argentina
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Brampton, Ontario, L6Y 1M5, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Santiago, Chile
Unknown Facility
Valparaíso, 2340000, Chile
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Bordeaux, 33076, France
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Bron, 69003, France
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Dijon, 21079, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75013, France
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Tours, 37044, France
Unknown Facility
Aguascalientes, 20030, Mexico
Unknown Facility
México, 04530, Mexico
Unknown Facility
Lima, Lima 33, Peru
Unknown Facility
Lima, Peru
Unknown Facility
San Cugat Del Valles, Barcelona, 08195, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20009, Spain
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Madrid, Madrid, 28046, Spain
Unknown Facility
Torremolinos, Malaga, 29620, Spain
Unknown Facility
El Palmar. Murcia, Murcia, 30120, Spain
Unknown Facility
Gothenburg, 411 19, Sweden
Unknown Facility
Belfast, BT12 6AB, United Kingdom
Unknown Facility
Dundee, DD1 9SY, United Kingdom
Unknown Facility
Edinburgh, EH10 5HF, United Kingdom
Unknown Facility
Glasgow, GS 8SJ, United Kingdom
Unknown Facility
London, W1W 7EJ, United Kingdom
Unknown Facility
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
July 11, 2016
Record last verified: 2016-07