Trials / Completed
CompletedNCT01750957
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 5 Years – 13 Years
- Healthy volunteers
- Not accepted
Summary
This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523 or placebo orally daily for 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | orally daily, 12 weeks |
| DRUG | RO4917523 | Dose A orally daily, 12 weeks |
| DRUG | RO4917523 | Dose B orally daily, 12 weeks |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2012-12-17
- Last updated
- 2016-08-11
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01750957. Inclusion in this directory is not an endorsement.