Phase 4
Completed N=367
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Source: ClinicalTrials.gov NCT01799941 ↗Enrolled (actual)
367
Serious AEs
6.3%
Results posted
Mar 2017
Primary outcomePrimary: Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90 — -7.69; -7.22; -7.59; -8.54 Units on a scale — p=<0.0001
◆ Published Evidence
Established
36citations · ~4 / year
PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury.
Summary
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.
Linked Publications (3)
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PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury.
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Safety, Tolerability, and Effectiveness of Dextromethorphan/Quinidine for Pseudobulbar Affect Among Study Participants With Traumatic Brain Injury: Results From the PRISM-II Open Label Study.
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An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90 |
-7.69; -7.22; -7.59; -8.54 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30 |
-5.43; -4.60; -6.17; -5.58 | <0.0001 sig |
| SECONDARY Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit |
21.33; 25.68; 19.62; 17.94; 9.10; 12.85 | <0.0001 sig |
| SECONDARY Percentage of Participants With PBA Remission |
20.3; 13.0; 22.5; 26.7; 35.4; 31.4 | — |
| SECONDARY Percentage Change From Baseline in PBA Episode Count Per Week |
-57.5; -50.0; -64.9; -61.3; -72.3; -67.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week |
63.7; 58.9; 65.0; 68.3; 78.0; 76.2 | — |
| SECONDARY Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week |
42.2; 33.6; 42.0; 53.7; 57.1; 57.4 | — |
| SECONDARY Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90 |
-3.13; -3.20; -2.66; -3.67 | <0.0001 sig |
| SECONDARY Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90 |
33.7; 30.4; 33.0; 39.7; 42.9; 47.1 | — |
| SECONDARY Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90 |
32.6; 28.4; 33.7; 37.3; 39.8; 48.0 | — |
| SECONDARY Percentage of Participants With Treatment Satisfaction Survey |
7.7; 4.9; 12.0; 6.0; 5.4; 6.9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
132; 49; 40; 43; 23; 14 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01799941) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.