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NCT04464564 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT04464564: Clinical Trial Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04464564 is a Phase 3 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04464564, a Phase 3 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study Summary
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
Primary Outcome
The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = o
Interventions
- DRUG Placebo
- DRUG AVP-786
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 3 |
Why NCT04464564 stopped before completion
NCT04464564 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04464564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04464564 about?
NCT04464564 is a clinical study titled "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". This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
What is the current status of trial NCT04464564?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2020-09-11. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT04464564?
The interventions under investigation include: Placebo (DRUG), AVP-786 (DRUG).
Who is sponsoring clinical trial NCT04464564?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04464564's enrollment target sits among peer trials
241 1272nd of 2000 higher than 728 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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