At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 139 enrolled
Drug / intervention
AFQ056 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X Syndrome
In Brief
A Phase 2 clinical trial evaluating AFQ056 and Placebo for Fragile X Syndrome. Completed, enrolled 139 participants across 38 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Indonesia, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedMay 20, 2011
Enrollment StartMay 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.1 years ago
Interventions
AFQ056drug
Placebodrug