Trials / Completed
CompletedNCT00718341
Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients
A Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Novartis · Industry
- Sex
- Male
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AF056 | |
| DRUG | Placebo |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2009-02-01
- First posted
- 2008-07-18
- Last updated
- 2020-02-11
Locations
3 sites across 3 countries: France, Italy, Switzerland
Source: ClinicalTrials.gov record NCT00718341. Inclusion in this directory is not an endorsement.