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.

Hoffmann-La Roche0 sites40 target enrollmentNovember 2009

ConditionsFragile X Syndrome

InterventionsPlacebo (for RO4917523 ascending doses)Placebo (for RO4917523 fixed dose)RO4917523

DrugsPlacebo (for RO4917523 ascending doses)Placebo (for RO4917523 fixed dose)RO4917523

Overview

Phase: Phase 2
Intervention: Placebo (for RO4917523 ascending doses)
Conditions: Fragile X Syndrome
Sponsor: Hoffmann-La Roche
Enrollment: 40
Primary Endpoint: Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

January 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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