Trials / Completed
CompletedNCT01253629
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate AFQ056 in Adult Patients With Fragile X Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AFQ056 | AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used |
| DRUG | Placebo | Placebo medication identical in appearance to active medication was provided |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2013-08-01
- Completion
- 2013-08-01
- First posted
- 2010-12-03
- Last updated
- 2020-12-23
Locations
31 sites across 10 countries: United States, Australia, Canada, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01253629. Inclusion in this directory is not an endorsement.