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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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 Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters [ Time Frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43 ]

Secondary Outcome Measures :
  1. Efficacy: Behavior and cognition assessments [ Time Frame: Every 2 weeks throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01015430     History of Changes
Other Study ID Numbers: NP22578
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Syndrome
Fragile X 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