PRISM II

CompletedPhase 4Results posted

Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)

A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)

Lead sponsor

Avanir Pharmaceuticals

Asset

Nuedexta

Listed sites

Recruiting sites

Enrollment

367

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥18

Primary endpoint

•Center for Neurologic Study-Lability Scale (CNS-LS) Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID12-AVR-401

NCT IDNCT01799941

Timeline

Milestones

Study start2013-02 (month precision)

Study first posted2013-02-27estimated

Primary completion2015-05actual (month precision)

Study completion2015-05actual (month precision)

Last update posted2017-03-15actual

Results first posted2017-03-15actual

Assets

Drug assets

Nuedexta

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater

•Clinical diagnosis of Pseudobulbar Affect (PBA)

•Documentation of Neurologic disease or brain injury

Exclusion criteria

•Unstable neurologic disease

•Severe dementia

•Stroke within 3 months

•Penetrating TBI

•Contraindications to Nuedexta

•Severe Depressive Disorder

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Caregiver / quality of life

Other (unclassified)

Memory

Safety / tolerability / PK

Other clinical outcomes

Memory

2 endpoints

Secondary/protocol endpoint

Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit

Time frame:Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)

event count, event

Secondary/registry result

Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit

Time frame:Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)

event count, event

Posted result

Group	Value (mean), Count/week	Standard deviation
OverallBaselinen=298 Participants	21.33	24.97
Day 30 (n= 296, 108, 102, 86)n=298 Participants	9.10	14.29
Day 90 (n= 260, 102, 92, 66)n=298 Participants	6.23	11.45
DementiaBaselinen=108 Participants	25.68	23.06
Day 30 (n= 296, 108, 102, 86)n=108 Participants	12.85	16.80
Day 90 (n= 260, 102, 92, 66)n=108 Participants	8.41	14.26
StrokeBaselinen=103 Participants	19.62	29.62
Day 30 (n= 296, 108, 102, 86)n=103 Participants	6.95	11.83
Day 90 (n= 260, 102, 92, 66)n=103 Participants	5.26	9.60
Traumatic Brain InjuryBaselinen=87 Participants	17.94	20.31
Day 30 (n= 296, 108, 102, 86)n=87 Participants	6.94	12.60
Day 90 (n= 260, 102, 92, 66)n=87 Participants	4.20	8.02

p<0.0001One-sample t-test

Day 30 versus Baseline

p<0.0001One-sample t-test

Day 90 versus Baseline

p<0.0001One-sample t-test

Day 30 versus Baseline

p<0.0001One-sample t-test

Day 90 assessment

p<0.0001One-sample t-test

Day 30 versus Baseline

p<0.0001One-sample t-test

Day 90 versus Baseline

p<0.0001One-sample t-test

Day 30 versus Baseline

p<0.0001One-sample t-test

Day 90 versus Baseline

Caregiver / quality of life

10 endpoints

Primary/protocol endpoint

Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90

Time frame:Day 90 (Final visit)

change from baseline, improvement

Primary/registry result

Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90

Time frame:Day 90 (Final visit)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Overalln=261 Participants	-7.69	6.07
Dementian=102 Participants	-7.22	6.04
Stroken=92 Participants	-7.59	6.67
Traumatic Brain Injuryn=67 Participants	-8.54	5.18

p<0.0001One sample t-test

The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.

p<0.0001one-sample t-test

The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.

p<0.0001One-sample t-test

The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.

p<0.0001One-sample t-test

The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.

Analysis of covariance (ANCOVA)0.0495% CI-1.37 - 1.45

ANCOVA1.1195% CI-0.46 - 2.68

ANCOVA1.1595% CI-0.39 - 2.69

Secondary/protocol endpoint

Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30

Time frame:Day 30

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90

Time frame:Day 90 (Final visit)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Treatment Satisfaction Survey

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Secondary/registry result

Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30

Time frame:Day 30

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Overalln=297 Participants	-5.43	5.52
Dementian=108 Participants	-4.60	5.08
Stroken=103 Participants	-6.17	6.12
Traumatic Brain Injuryn=86 Participants	-5.58	5.21

p<0.0001One-sample t-test

Secondary/registry result

Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90

Time frame:Day 90 (Final visit)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Overalln=298 Participants	-3.13	3.21
Dementian=108 Participants	-3.20	2.98
Stroken=103 Participants	-2.66	3.35
Traumatic Brain Injuryn=87 Participants	-3.67	3.29

p<0.0001One-sample t-test

Secondary/registry result

Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallVery much improvedn=261 Participants	32.6	-
Much improvedn=261 Participants	39.8	-
Minimally improvedn=261 Participants	18.8	-
No changen=261 Participants	8.0	-
Minimally worsen=261 Participants	0.4	-
Much worsen=261 Participants	0.4	-
Veru much worsen=261 Participants	0.0	-
DementiaVery much improvedn=102 Participants	28.4	-
Much improvedn=102 Participants	48.0	-
Minimally improvedn=102 Participants	14.7	-
No changen=102 Participants	7.8	-
Minimally worsen=102 Participants	1.0	-
Much worsen=102 Participants	0.0	-
Veru much worsen=102 Participants	0.0	-
StrokeVery much improvedn=92 Participants	33.7	-
Much improvedn=92 Participants	33.7	-
Minimally improvedn=92 Participants	21.7	-
No changen=92 Participants	10.9	-
Minimally worsen=92 Participants	0.0	-
Much worsen=92 Participants	0.0	-
Veru much worsen=92 Participants	0.0	-
Traumatic Brain InjuryVery much improvedn=67 Participants	37.3	-
Much improvedn=67 Participants	35.8	-
Minimally improvedn=67 Participants	20.9	-
No changen=67 Participants	4.5	-
Minimally worsen=67 Participants	0.0	-
Much worsen=67 Participants	1.5	-
Veru much worsen=67 Participants	0.0	-

Secondary/registry result

Percentage of Participants With Treatment Satisfaction Survey

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallVery dissatisfiedn=261 Participants	7.7	-
Somewhat dissatisfiedn=261 Participants	5.4	-
Neither satisfied nor dissatisfiedn=261 Participants	11.5	-
Somewhat satisfiedn=261 Participants	28.0	-
Very satisfiedn=261 Participants	47.5	-
DementiaVery dissatisfiedn=102 Participants	4.9	-
Somewhat dissatisfiedn=102 Participants	6.9	-
Neither satisfied nor dissatisfiedn=102 Participants	13.7	-
Somewhat satisfiedn=102 Participants	21.6	-
Very satisfiedn=102 Participants	52.9	-
StrokeVery dissatisfiedn=92 Participants	12.0	-
Somewhat dissatisfiedn=92 Participants	5.4	-
Neither satisfied nor dissatisfiedn=92 Participants	8.7	-
Somewhat satisfiedn=92 Participants	31.5	-
Very satisfiedn=92 Participants	42.4	-
Traumatic Brain InjuryVery dissatisfiedn=67 Participants	6.0	-
Somewhat dissatisfiedn=67 Participants	3.0	-
Neither satisfied nor dissatisfiedn=67 Participants	11.9	-
Somewhat satisfiedn=67 Participants	32.8	-
Very satisfiedn=67 Participants	46.3	-

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days

event count, event

Secondary/registry result

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
OverallAEsn=367 Participants	132	-
SAEsn=367 Participants	23	-
DementiaAEsn=134 Participants	49	-
SAEsn=134 Participants	14	-
StrokeAEsn=113 Participants	40	-
SAEsn=113 Participants	5	-
Traumatic Brain InjuryAEsn=120 Participants	43	-
SAEsn=120 Participants	4	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Secondary/registry result

Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90

Time frame:Day 90 (Final visit)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallVery much improvedn=261 Participants	33.7	-
Much improvedn=261 Participants	42.9	-
Minimally improvedn=261 Participants	13.4	-
No changen=261 Participants	8.8	-
Minimally worsen=261 Participants	0.8	-
Much worsen=261 Participants	0.4	-
Veru much worsen=261 Participants	0.0	-
DementiaVery much improvedn=102 Participants	30.4	-
Much improvedn=102 Participants	47.1	-
Minimally improvedn=102 Participants	13.7	-
No changen=102 Participants	8.8	-
Minimally worsen=102 Participants	0.0	-
Much worsen=102 Participants	0.0	-
Veru much worsen=102 Participants	0.0	-
StrokeVery much improvedn=91 Participants	33.0	-
Much improvedn=91 Participants	41.8	-
Minimally improvedn=91 Participants	14.3	-
No changen=91 Participants	7.7	-
Minimally worsen=91 Participants	2.2	-
Much worsen=91 Participants	1.1	-
Veru much worsen=91 Participants	0.0	-
Traumatic Brain InjuryVery much improvedn=68 Participants	39.7	-
Much improvedn=68 Participants	38.2	-
Minimally improvedn=68 Participants	11.8	-
No changen=68 Participants	10.3	-
Minimally worsen=68 Participants	0.0	-
Much worsen=68 Participants	0.0	-
Veru much worsen=68 Participants	0.0	-

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Percentage of Participants With PBA Remission

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage Change From Baseline in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

change from baseline, improvement

Secondary/registry result/low confidence

Percentage of Participants With PBA Remission

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallDay 30 (n= 296, 108, 102, 86)n=298 Participants	20.3	-
Day 90 (n= 260, 102, 92, 66)n=298 Participants	35.4	-
DementiaDay 30 (n= 296, 108, 102, 86)n=108 Participants	13.0	-
Day 90 (n= 260, 102, 92, 66)n=108 Participants	31.4	-
StrokeDay 30 (n= 296, 108, 102, 86)n=103 Participants	22.5	-
Day 90 (n= 260, 102, 92, 66)n=103 Participants	34.8	-
Traumatic Brain InjuryDay 30 (n= 296, 108, 102, 86)n=87 Participants	26.7	-
Day 90 (n= 260, 102, 92, 66)n=87 Participants	42.4	-

Secondary/registry result/low confidence

Percentage Change From Baseline in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	Reported bounds
OverallDay 30 (n= 296, 108, 102, 86)n=298 Participants	-57.5	--59.3 - -55.5
Day 90 (n=260, 102, 92, 66)n=298 Participants	-72.3	--73.8 - -70.8
DementiaDay 30 (n= 296, 108, 102, 86)n=108 Participants	-50.0	--53.1 - -46.6
Day 90 (n=260, 102, 92, 66)n=108 Participants	-67.7	--70.1 - -65.1
StrokeDay 30 (n= 296, 108, 102, 86)n=103 Participants	-64.9	--67.7 - -61.7
Day 90 (n=260, 102, 92, 66)n=103 Participants	-74.5	--76.9 - -71.8
Traumatic Brain InjuryDay 30 (n= 296, 108, 102, 86)n=87 Participants	-61.3	--64.8 - -57.7
Day 90 (n=260, 102, 92, 66)n=87 Participants	-78.5	--81.2 - -75.7

Incidence Rate Ratio0.42595% CI0.407 - 0.445p<0.0001Mixed Effects Poisson Regreesion Model

Day 30 assessment

Incidence Rate Ratio0.27795% CI0.262 - 0.293p<0.0001Mixed Effects Poisson Regression Model

Day 90 assessment

Incidence Rate Ratio0.50095% CI0.469 - 0.534p<0.0001Mixed Effects Poisson Regression Model

Day 30 assessment

Incidence Rate Ratio0.32395% CI0.299 - 0.349p<0.0001Mixed Effects Poisson Regression Model

Day 90 assessment

Incidence Rate Ratio0.35195% CI0.323 - 0.383p<0.0001Mixed Effects Poisson Regression Model

Day 30 assessment

Incidence Rate Ratio0.25595% CI0.231 - 0.282p<0.0001Mixed Effects Poisson Regression Model

Day 90 assessment

Incidence Rate Ratio0.38795% CI0.352 - 0.425p<0.0001Mixed Effects Poisson Regression Model

Day 30 assessment

Incidence Rate Ratio0.21595% CI0.189 - 0.245p<0.0001Mixed Effects Poisson Regression Model

Day 90 assessment

Secondary/registry result/low confidence

Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

change from baseline, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallDay 30 (n= 289, 107, 100, 82)n=298 Participants	63.7	-
Day 90 (n= 254, 101, 90, 63)n=298 Participants	78.0	-
DementiaDay 30 (n= 289, 107, 100, 82)n=108 Participants	58.9	-
Day 90 (n= 254, 101, 90, 63)n=108 Participants	76.2	-
StrokeDay 30 (n= 289, 107, 100, 82)n=103 Participants	65.0	-
Day 90 (n= 254, 101, 90, 63)n=103 Participants	76.7	-
Traumatic Brain InjuryDay 30 (n= 289, 107, 100, 82)n=87 Participants	68.3	-
Day 90 (n= 254, 101, 90, 63)n=87 Participants	82.5	-

Secondary/registry result/low confidence

Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week

Time frame:Day 30 (Visit 1) and Day 90 (Final visit)

change from baseline, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
OverallDay 30 (n= 289, 107, 100, 82)n=298 Participants	42.2	-
Day 90 (n= 254, 101, 90, 63)n=298 Participants	57.1	-
DementiaDay 30 (n= 289, 107, 100, 82)n=108 Participants	33.6	-
Day 90 (n= 254, 101, 90, 63)n=108 Participants	57.4	-
StrokeDay 30 (n= 289, 107, 100, 82)n=103 Participants	42.0	-
Day 90 (n= 254, 101, 90, 63)n=103 Participants	47.8	-
Traumatic Brain InjuryDay 30 (n= 289, 107, 100, 82)n=87 Participants	53.7	-
Day 90 (n= 254, 101, 90, 63)n=87 Participants	69.8	-

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.