NCT01357239

Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 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

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	AFQ056
DRUG	Placebo

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-05-20
• Last updated: 2015-05-12
• Results posted: 2015-05-12

Locations

38 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Indonesia, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom