Trials / Completed
CompletedNCT01015430
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo (for RO4917523 ascending doses) | Placebo daily po |
| DRUG | Placebo (for RO4917523 fixed dose) | Placebo daily po |
| DRUG | RO4917523 | RO4917523 ascending doses daily po |
| DRUG | RO4917523 | RO4917523 fixed dose daily po |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2009-11-18
- Last updated
- 2016-11-02
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01015430. Inclusion in this directory is not an endorsement.