Deudextromethorphan
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03420222 | Jan → Dec 2018 | intermittent explosive disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02153502 | Jul 2014 → Feb 2016 | major depressive disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03896945 | Feb 2019 → May 2023 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT04464564 | Sep 2020 → Jun 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04408755 | Jul 2020 → Jun 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03393520 | Oct 2017 → Nov 2023 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02446132 | Nov 2015 → Sep 2024 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02442778 | Nov 2015 → Aug 2019 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Missed primary |
| Phase 3 | NCT02442765 | Jul 2015 → Jan 2019 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Mixed |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-09-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka's Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗
The trial did not meet its primary endpoint and key secondary endpoints. |
| 2019-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗
Similar improvements were also observed on the key secondary endpoint. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-09-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka's Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗ |
| 2019-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia otsuka.co.jp ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Deudextromethorphan | “A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide...” NCT04408755 ↗5“AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type” NCT03393520 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)” NCT03420222 ↗ “18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)” NCT02442778 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q])” NCT04464564 ↗ |
| Known as | d6-dextromethorphan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02153502 ↗ |
| Known as | d6-dextromethorphan hydrobromide | “AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)” NCT02153502 ↗ |
| Known as | d6-DM | “Participants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo...” NCT03896945 ↗7“A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide...” NCT04408755 ↗ “A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the...” NCT02446132 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type” NCT03393520 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)” NCT03420222 ↗ “18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)” NCT02442778 ↗ “Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]” NCT02442765 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q])” NCT04464564 ↗ |
| Known as | Deudextromethorphan Hydrobromide | “Participants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo...” NCT03896945 ↗5“A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide...” NCT04408755 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type” NCT03393520 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)” NCT03420222 ↗ “18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q)” NCT02442778 ↗ “AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q])” NCT04464564 ↗ |
| Known as | Deuterated [d6] Dextromethorphan Hydrobromide | “A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the...” NCT02446132 ↗1“Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]” NCT02442765 ↗ |
| Route | Oral | “Study medication will be administered orally twice a day (BID)” NCT02153502 ↗ |