4 terminated, 2 completed. 6 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Terminated 4, Completed 2 |
| Phase 2 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 241 | 2020-09-11 | 2025-05-30 |
| Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 184 | 2020-07-13 | 2025-05-30 |
| Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia Placebo, AVP-786 - Schizophrenia | Phase 2 / Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 136 | 2019-02-15 | 2026-09-29 |
| Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type Placebo, AVP-786 - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 601 | 2017-10-13 | 2024-11-20 |
| Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786 - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1197 | 2015-11-13 | 2025-10-15 |
| Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type AVP-786, Placebo - Agitation in Patients With Dementia of the Alzheimer's Type | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 387 | 2015-07-23 | 2023-02-13 |
Alzheimer Disease (4) · Psychomotor Agitation (4) · Dementia (1) · Schizophrenia (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (6)
United States (6) · Poland (5) · Bulgaria (4) · Hungary (3) · Puerto Rico (3) · Spain (3) · Canada (2) · Czechia (2) · Estonia (2) · France (2) · Germany (2) · Italy (2) · Portugal (2) · South Africa (2) · United Kingdom (2)
2017 (2), 2023 (2)