Trials / Completed
CompletedNCT02024789
A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 12 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Orally twice daily, 26 weeks |
| DRUG | RG1662 | 120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks |
| DRUG | RG1662 | 240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks |
Timeline
- Start date
- 2014-05-05
- Primary completion
- 2016-05-04
- Completion
- 2016-05-04
- First posted
- 2013-12-31
- Last updated
- 2017-10-25
Locations
37 sites across 10 countries: United States, Argentina, Canada, France, Italy, Mexico, New Zealand, Singapore, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02024789. Inclusion in this directory is not an endorsement.