A Study With RO4917523 in Patients With Fragile X Syndrome
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ClinicalTrials.gov Identifier: NCT01015430 |
Recruitment Status :
Completed
First Posted : November 18, 2009
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fragile X Syndrome | Drug: Placebo (for RO4917523 ascending doses) Drug: Placebo (for RO4917523 fixed dose) Drug: RO4917523 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo (for RO4917523 ascending doses) |
Drug: Placebo (for RO4917523 ascending doses)
Placebo daily po Drug: Placebo (for RO4917523 fixed dose) Placebo daily po |
Placebo Comparator: Placebo (for RO4917523 fixed dose) |
Drug: Placebo (for RO4917523 ascending doses)
Placebo daily po Drug: Placebo (for RO4917523 fixed dose) Placebo daily po |
Experimental: RO4917523 ascending doses |
Drug: RO4917523
RO4917523 ascending doses daily po |
Experimental: RO4917523 fixed dose |
Drug: RO4917523
RO4917523 fixed dose daily po |
- Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters [ Time Frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43 ]
- Efficacy: Behavior and cognition assessments [ Time Frame: Every 2 weeks throughout study ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients, 18 to 50 years of age
- Fragile X Syndrome
- IQ less than 75
- Reliable caregiver
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015430
United States, California | |
Sacramento, California, United States, 95817 | |
United States, Georgia | |
Decatur, Georgia, United States, 30033 | |
United States, Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46202 | |
United States, Tennessee | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01015430 |
Other Study ID Numbers: |
NP22578 |
First Posted: | November 18, 2009 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Fragile X Syndrome Syndrome Disease Pathologic Processes Mental Retardation, X-Linked Intellectual Disability 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 |