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A Study With RO4917523 in Patients With Fragile X Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01015430
First received: November 17, 2009
Last updated: December 5, 2011
Last verified: December 2011
History of Changes

November 17, 2009
December 5, 2011
November 2009
September 2011   (final data collection date for primary outcome measure)
Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters [ Time Frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01015430 on ClinicalTrials.gov Archive Site
Efficacy: Behavior and cognition assessments [ Time Frame: Every 2 weeks throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fragile X Syndrome
  • Drug: RO4917523
    RO4917523 ascending doses daily po
  • Drug: Placebo
    Placebo daily po
  • Drug: RO4917523
    RO4917523 fixed dose daily po
  • Experimental: 1
    Intervention: Drug: RO4917523
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 3
    Intervention: Drug: RO4917523
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01015430
NP22578
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP