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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01015430 |
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Date of registration:
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17/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study With RO4917523 in Patients With Fragile X Syndrome
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Scientific title:
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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. |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01015430 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Intervention(s)
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Drug: RO4917523
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Drug: Placebo (for RO4917523 ascending doses)
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Drug: Placebo (for RO4917523 fixed dose)
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Primary Outcome(s)
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Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters
[Time Frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43]
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Secondary Outcome(s)
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Efficacy: Behavior and cognition assessments
[Time Frame: Every 2 weeks throughout study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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