AVP-786
Sponsors
Otsuka Pharmaceutical Development & Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization Inc., Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions
Agitation in Patients With Dementia of the Alzheimer's TypeDisinhibition SyndromeDrug-drug InteractionHealthyHealthy VolunteerIntermittent Explosive DisorderSchizophrenia
Phase 1
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
CompletedNCT02174835
Start: 2013-09-01End: 2013-11-01Updated: 2026-04-28
A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
CompletedNCT02174822
Start: 2014-01-31End: 2014-04-30Updated: 2022-02-18
A Phase 1 Study Comparing AVP-786 With AVP-923
CompletedNCT02336347
Start: 2014-05-01End: 2015-03-01Updated: 2026-04-28
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
CompletedNCT02402595
Start: 2015-03-01End: 2015-07-01Updated: 2026-04-28
Phase 2
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
CompletedNCT02477670
Start: 2015-09-01End: 2017-07-21Updated: 2026-05-13
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
TerminatedNCT02534038
Start: 2015-12-01End: 2017-10-03Updated: 2026-05-13
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
TerminatedNCT03420222
Start: 2018-01-18End: 2018-12-28Updated: 2022-05-24
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
TerminatedNCT03896945
Start: 2019-02-15End: 2023-05-23Updated: 2024-05-24
Phase 3
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
CompletedNCT02442765
Start: 2015-07-23End: 2019-02-27Updated: 2023-02-13
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
TerminatedNCT02446132
Start: 2015-11-13End: 2024-09-06Updated: 2025-10-15
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
CompletedNCT03393520
Start: 2017-10-13End: 2023-12-14Updated: 2024-11-20
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
TerminatedNCT04408755
Start: 2020-07-13End: 2024-06-27Updated: 2025-05-30
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
TerminatedNCT04464564
Start: 2020-09-11End: 2024-06-28Updated: 2025-05-30
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess 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
CompletedCTIS2023-504991-31-00
Start: 2021-05-06End: 2024-05-22Target: 248Updated: 2024-04-29
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess 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
CompletedCTIS2023-504990-19-00
Start: 2021-04-06End: 2024-05-22Target: 267Updated: 2024-05-29