Drugs / AVP-786
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02402595 | Mar → Jul 2015 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02336347 | May → Sep 2014 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02174822 | Jan → Mar 2014 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02174835 | Sep → Nov 2013 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01787747 | Oct 2012 → Feb 2013 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT03095066 | May 2017 → Aug 2022 | neurodevelopmental disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Missed primary |
| Phase 2 | NCT02477670 | Sep 2015 → Jul 2017 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02534038 Comparator | Dec 2015 → Oct 2017 | impulse control disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-02-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease otsuka.co.jp ↗
A statistically significant difference was not achieved on the primary efficacy endpoint, mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo. |
| 2024-02-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated With Dementia Due to Alzheimer’s Disease otsuka-us.com ↗
A statistically significant difference was not achieved on the primary efficacy endpoint, mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo. |
| 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 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVP-786 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02402595 ↗ |
| Known as | Deuterated Dextromethorphan | “AVP-786 (Deuterated Dextromethorphan)” NCT01787747 ↗ |
| Route | Oral | “AVP-786 twice daily orally for Days 13 - 20.” NCT02174822 ↗ |