A Study With RO4917523 in Patients With Fragile X Syndrome
A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.
1 other identifier
interventional
40
1 country
5
Brief Summary
This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is \<100 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 17, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedNovember 2, 2016
November 1, 2016
1.2 years
November 17, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters
AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43
Secondary Outcomes (1)
Efficacy: Behavior and cognition assessments
Every 2 weeks throughout study
Study Arms (4)
Placebo (for RO4917523 ascending doses)
PLACEBO COMPARATORPlacebo (for RO4917523 fixed dose)
PLACEBO COMPARATORRO4917523 ascending doses
EXPERIMENTALRO4917523 fixed dose
EXPERIMENTALInterventions
Placebo daily po
Placebo daily po
Eligibility Criteria
You may qualify if:
- Adult patients, 18 to 50 years of age
- Fragile X Syndrome
- IQ less than 75
- Reliable caregiver
You may not qualify if:
- Current psychosis or presumption of psychosis
- History of suicidal behavior or considered a high suicidal risk
- Severe self-injurious behavior
- Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
- Current seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
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
November 17, 2009
First Posted
November 18, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11