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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06502964 | Study of ALTO-101 in Patients With Schizophrenia | PHASE2 | RECRUITING | 82 | — | — | Jun 11, 2024 | Mar 1, 2026 | Dec 26, 2025 | 14 | United States |
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
| Arm | Type | Description |
|---|---|---|
| ALTO-101 | EXPERIMENTAL | 10 days administration of ALTO-101T transdermal delivery system |
| Placebo | PLACEBO_COMPARATOR | 10 days administration of placebo transdermal delivery system |
| Name | Type | Description |
|---|---|---|
| ALTO-101 | DRUG | ALTO-101 patches |
| ALTO-101 Transdermal Delivery System | DEVICE | ALTO-101 transdermal delivery system |
| Placebo | DRUG | Inactive placebo patches |
| Placebo Transdermal Delivery System | DEVICE | Placebo transdermal delivery system |
Inclusion Criteria: * Schizophrenia diagnosis for at least one year * Cognitive impairment * Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2 * Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening * Have a bod...