Trial · NCT01584440

Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease

NCT01584440, Phase 2, Completed, Avanir Pharmaceuticals; results first posted 2021-11-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease. Trials, record NCT01584440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01584440

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
NCT number: NCT01584440
Status: Completed
Phases: Phase 2
Enrollment: 220 participants, actual
Lead sponsor: Avanir Pharmaceuticals
Conditions: Agitation, Alzheimer's Disease
Interventions: AVP-923-20, Placebo, AVP-923-30
First posted: 2012-04-25
Last updated: 2021-11-26
Results first posted: 2021-11-26

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	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 frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Data are reported for only those participants contributing data to the analysis.
Secondary	Number of Participants With the Indicated Type of Adverse Event	up to Week 10	Treatment-emergent adverse events (TEAEs) are defined as AEs that first occurred, or worsened, after the first dose of study medication and within 30 days after the permanent discontinuation of the study medication (first dose date ≤ AE start date ≤ date of last dose + 30 days)
Secondary	Change in the Total NPI Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The total score is calculated as a sum of all 12 domain scores and thus ranges from 12 to 144. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the Individual NPI Domain Scores From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Sleep/nighttime behavior disorders = S/NB disorders.
Secondary	Change in the Sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior NPI Domain (NPI4D) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4D score is the sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the Sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior NPI Domain (NPI4A) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4A score is the sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the Total Neuropsychiatric Inventory-Caregiver Distress Score (NPI-CDS) From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For each domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The total NPI-CDS score is calculated as the sum of all 12 domain scores and thus ranges from 0 to 60. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the NPI-CDS for the Agitation/Aggression Domain From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the Agitation/Aggression domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the NPI-CDS NPI4D Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4D NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4D NPI-CDS score ranges from 0 to 20. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Secondary	Change in the NPI-CDS NPI4A Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4A NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4A NPI-CDS score ranges from 0 to 20. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 modified Intent-to-Treat (mITT) Population: all participants randomized in Stage 1 who had at least one post-Baseline NPI agitation/aggression score in Stage 1. Stage 2 mITT Population: all placebo non-responders from Stage 1 who were re-randomized in Stage 2 and had at least one post-Week 4 NPI agitation/aggression score in Stage 2	score on a scale	MEAN
SECONDARY	Number of Participants With the Indicated Type of Adverse Event	up to Week 10	Safety Population: all randomized participants who received at least one dose of study treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in the Total NPI Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Population. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the Individual NPI Domain Scores From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Population. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the Sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior NPI Domain (NPI4D) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the Sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior NPI Domain (NPI4A) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the Total Neuropsychiatric Inventory-Caregiver Distress Score (NPI-CDS) From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the NPI-CDS for the Agitation/Aggression Domain From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the NPI-CDS NPI4D Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN
SECONDARY	Change in the NPI-CDS NPI4A Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70	Stage 1 and Stage 2 mITT Populations. Data are reported for only those participants contributing data to the analysis.	score on a scale	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group237

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Placebo	Day 36	-1.7	Standard Deviation 3.10	score on a scale
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	AVP-923	Day 36	-3.3	Standard Deviation 2.98	score on a scale
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	Placebo	Day 70	-0.8	Standard Deviation 3.59	score on a scale
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70	AVP-923	Day 70	-2.0	Standard Deviation 3.19	score on a scale
Number of Participants With the Indicated Type of Adverse Event	All AVP-923	Participants with ≥ 1 TEAE	93		Participants
Number of Participants With the Indicated Type of Adverse Event	Placebo	Participants with ≥ 1 TEAE	55		Participants
Number of Participants With the Indicated Type of Adverse Event	All AVP-923	Participants with discontinuations due to a TEAE	8		Participants
Number of Participants With the Indicated Type of Adverse Event	Placebo	Participants with discontinuations due to a TEAE	4		Participants
Number of Participants With the Indicated Type of Adverse Event	All AVP-923	Participants who died	0		Participants
Number of Participants With the Indicated Type of Adverse Event	Placebo	Participants who died	0		Participants

1 to 10 of 237Source ClinicalTrials.gov

See all 237 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Stage 1 (5 Weeks)	STARTED	Stage 1: AVP-923	93
Stage 1 (5 Weeks)	STARTED	Stage 1: Placebo	127
Stage 1 (5 Weeks)	STARTED	AVP-923 in Stage 1/AVP-923 in Stage 2	0
Stage 1 (5 Weeks)	STARTED	Placebo in Stage 1/AVP-923 in Stage 2	0
Stage 1 (5 Weeks)	STARTED	Placebo in Stage 1/Placebo in Stage 2	0
Stage 1 (5 Weeks)	COMPLETED	Stage 1: AVP-923	83
Stage 1 (5 Weeks)	COMPLETED	Stage 1: Placebo	119
Stage 1 (5 Weeks)	COMPLETED	AVP-923 in Stage 1/AVP-923 in Stage 2	0
Stage 1 (5 Weeks)	COMPLETED	Placebo in Stage 1/AVP-923 in Stage 2	0
Stage 1 (5 Weeks)	COMPLETED	Placebo in Stage 1/Placebo in Stage 2	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	AVP-923 in Stage 1/AVP-923 in Stage 2	5	93
other	Diarrhoea	Gastrointestinal disorders	Placebo in Stage 1/AVP-923 in Stage 2	4	59
other	Diarrhoea	Gastrointestinal disorders	Placebo in Stage 1/Placebo in Stage 2	4	68
other	Urinary Tract Infection	Infections and infestations	AVP-923 in Stage 1/AVP-923 in Stage 2	5	93
other	Urinary Tract Infection	Infections and infestations	Placebo in Stage 1/AVP-923 in Stage 2	3	59
other	Urinary Tract Infection	Infections and infestations	Placebo in Stage 1/Placebo in Stage 2	4	68
other	Fall	Injury, poisoning and procedural complications	AVP-923 in Stage 1/AVP-923 in Stage 2	10	93
other	Fall	Injury, poisoning and procedural complications	Placebo in Stage 1/AVP-923 in Stage 2	3	59
other	Fall	Injury, poisoning and procedural complications	Placebo in Stage 1/Placebo in Stage 2	4	68
other	Back Pain	Musculoskeletal and connective tissue disorders	AVP-923 in Stage 1/AVP-923 in Stage 2	0	93

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AVP-923 in Stage 1/AVP-923 in Stage 2	0	93
Total, all-cause mortality	Placebo in Stage 1/AVP-923 in Stage 2	0	59
Total, all-cause mortality	Placebo in Stage 1/Placebo in Stage 2	0	68
Total, other adverse events	AVP-923 in Stage 1/AVP-923 in Stage 2	24	93
Total, other adverse events	Placebo in Stage 1/AVP-923 in Stage 2	12	59
Total, other adverse events	Placebo in Stage 1/Placebo in Stage 2	17	68
Total, serious adverse events	AVP-923 in Stage 1/AVP-923 in Stage 2	9	93
Total, serious adverse events	Placebo in Stage 1/AVP-923 in Stage 2	3	59
Total, serious adverse events	Placebo in Stage 1/Placebo in Stage 2	6	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26393847	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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