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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05686239 | A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS) | PHASE2 | COMPLETED | 242 | — | — | Dec 8, 2022 | Apr 9, 2025 | Jul 30, 2025 | 36 | United States, Bulgaria +2 |
change from baseline in composite of nine cognitive tests
| Arm | Type | Description |
|---|---|---|
| RL-007 20 mg (Inidascamine) | EXPERIMENTAL | oral dosing three times per day (TID) |
| RL-007 40 mg (Inidascamine) | EXPERIMENTAL | oral dosing three times per day (TID) |
| Placebo | PLACEBO_COMPARATOR | oral dosing three times per day (TID) |
| Name | Type | Description |
|---|---|---|
| RL-007 (Inidascamine) | DRUG | investigational study drug |
| Placebo | DRUG | placebo capsules matching the appearance and size of the active drug |
Key Inclusion Criteria: * Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months * Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive) * Currently treated on a single atypical antipsychotic (other tha...