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NCT01584440 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
A Phase 2 study, sponsored by Avanir Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
NCT01584440: Completed Phase 2 study, sponsored by Avanir Pharmaceuticals.
NCT01584440 is a Phase 2 study that has completed, run by Avanir Pharmaceuticals. The registered enrollment target is 220 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01584440, a Phase 2 study, has completed, sponsored by Avanir Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
Study Summary
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
Primary Outcome
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable Alzheimer's Disease (AD) and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequenc
Interventions
- DRUG Placebo
- DRUG AVP-923-30
- DRUG AVP-923-20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-08-13 |
| Est. Completion | 2014-07-30 |
| Phase | Phase 2 |
What the finished NCT01584440 record still lists
NCT01584440 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01584440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01584440 about?
NCT01584440 is a clinical study titled "Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease". The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
What is the current status of trial NCT01584440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2012-08-13. Estimated completion is 2014-07-30.
What interventions are being tested in trial NCT01584440?
The interventions under investigation include: Placebo (DRUG), AVP-923-30 (DRUG), AVP-923-20 (DRUG).
Who is sponsoring clinical trial NCT01584440?
This trial is sponsored by Avanir Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01584440's enrollment target sits among peer trials
220 275th of 2000 higher than 1,718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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