7 completed, 6 terminated. 6 Phase 3, 4 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Terminated 4, Completed 2 |
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 4 | Terminated 3, Completed 1 |
Follow AVP-786: new trials by email Literature Review of AVP-786 trials Research Report on AVP-786
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 |
| Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder AVP-786, Placebo - Intermittent Explosive Disorder | Phase 2 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 10 | 2018-01-18 | 2022-05-24 |
| 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 |
| Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition AVP-786, Placebo - Disinhibition Syndrome | Phase 2 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1 | 2015-12-01 | 2026-05-13 |
| 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 Residual Schizophrenia AVP-786, Placebo - Schizophrenia | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 145 | 2015-09-01 | 2026-05-13 |
| 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 |
| Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts AVP-923, AVP-786, Itraconazole - Healthy | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 24 | 2015-03-01 | 2026-04-28 |
| A Phase 1 Study Comparing AVP-786 With AVP-923 AVP-786, AVP-923 - Healthy Volunteer | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 62 | 2014-05-01 | 2026-04-28 |
| A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects AVP-786, Paroxetine, Duloxetine - Drug-drug Interaction | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 56 | 2014-01-01 | 2022-02-18 |
| A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers AVP-786, AVP-923 - Healthy | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 56 | 2013-09-01 | 2026-04-28 |
Alzheimer Disease (4) · Psychomotor Agitation (4) · Schizophrenia (2) · Dementia (1) · Disruptive, Impulse Control, and Conduct Disorders (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (13)
United States (11) · Poland (5) · Bulgaria (4) · Australia (3) · Hungary (3) · Puerto Rico (3) · Spain (3) · Canada (2) · Czechia (2) · Estonia (2) · France (2) · Germany (2) · Italy (2) · Portugal (2) · South Africa (2)
Jason Lickliter, MBBS PhD FRACP (1)
2017 (2), 2023 (2)