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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01730768 | A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients | PHASE2 | COMPLETED | 147 | — | — | Sep 1, 2012 | Dec 1, 2013 | Dec 24, 2020 | 13 | United States |
| NCT00825539 | Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia | PHASE1 | COMPLETED | 68 | — | — | Jan 1, 2009 | Nov 1, 2011 | Dec 24, 2020 | 7 | United States |
The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.
| Arm | Type | Description |
|---|---|---|
| AQW051 10 mg/day | EXPERIMENTAL | Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84. |
| Placebo to AQW051 | PLACEBO_COMPARATOR | Matching placebo administered orally. |
| Placebo | PLACEBO_COMPARATOR | - |
| AQW051 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AQW051 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Diagnosis of schizophrenia * Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. * Spec...