NCT01517698

A Study of RO4917523 in Patients With Fragile X Syndrome

A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	placebo to RO4917523 orally once a day for 12 weeks
DRUG	RO4917523 0.5 mg	0.5 mg orally once a day for 12 weeks
DRUG	RO4917523 1.5 mg	1.5 mg orally once a day for 12 weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-01-25
• Last updated: 2016-07-11

Locations

51 sites across 10 countries: United States, Argentina, Canada, Chile, France, Mexico, Peru, Spain, Sweden, United Kingdom