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NCT03393520 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
NCT03393520: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03393520 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 601 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393520, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
Study Summary
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
Interventions
- DRUG Placebo
- DRUG AVP-786
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 3 |
What the finished NCT03393520 record still lists
NCT03393520 is an interventional study that assigns participants to a tested intervention. The registered 601 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 (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03393520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03393520 about?
NCT03393520 is a clinical study titled "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". This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
What is the current status of trial NCT03393520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2017-10-13. Estimated completion is 2023-12-14.
What interventions are being tested in trial NCT03393520?
The interventions under investigation include: Placebo (DRUG), AVP-786 (DRUG).
Who is sponsoring clinical trial NCT03393520?
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 NCT03393520's enrollment target sits among peer trials
601 608th of 2000 higher than 1,393 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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