deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT04408755

Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Interventions AVP-786 Placebo
Updated 40 times since 2020 Last updated: May 12, 2025 Started: Jul 13, 2020 Primary completion: Jun 27, 2024 Completion: Jun 27, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.

This PHASE3 trial investigates Agitation in Patients With Dementia of the Alzheimer's Type and is currently terminated or withdrawn. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 40 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Feb 2024 · 5 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Feb 2025 · 3 months · monthly snapshot~Feb 2025 – ~Jun 2025 · 4 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

40 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Jun 2025 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Feb 2025 — Jun 2025 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

  4. Nov 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE3

Show 35 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  2. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  3. Apr 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  4. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  5. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  6. Sep 2023 — Feb 2024 [monthly]

    Recruiting PHASE3

  7. Jul 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  8. May 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  9. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  10. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  11. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  12. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  13. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  14. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  15. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  16. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  17. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  18. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  19. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  20. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  21. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  22. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  23. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  24. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  25. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  26. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  27. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  28. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  29. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  30. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  31. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  32. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  33. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  34. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE3

  35. Jun 2020 — Jul 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Otsuka Pharmaceutical Development & Commercialization, Inc.
Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .