Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00718341 | Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients | PHASE2 | COMPLETED | 30 | — | — | Jun 1, 2008 | - | Feb 11, 2020 | 3 | France, Italy +1 |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AF056 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male, non-smoking patients between 18 and 35 years of age (both inclusive). * Patients with fmr1 full mutation (\> 200 CGG repeats) * Patients with a Clinical Global Impression Severity Score (CGI-S) of \> 4 (moderately ill) * Patients with a score of \>20 in the ABC-C scale (...