Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)

Study Overview
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Brief Summary
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6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.

Detailed Description
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Eligible patients for this study must have a diagnosis of a neurological disorder affecting the brain of at least 3 months duration prior to baseline and which is not rapidly progressing and must have a diagnosis of Pseudobulbar affect (PBA). This is a multicenter, open label study consisting of 6 months of treatment. Approximately 125 patients will be enrolled at approximately 25 centers in the United States.

Official Title
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A Study to Assess Effectiveness, Safety, and Health-related Outcomes of NUEDEXTA® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the Treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients

Conditions
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Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Intervention / Treatment
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* Drug: NUEDEXTA®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration prior to baseline and which is not rapidly progressing Diagnosis of Pseudobulbar Affect (PBA) A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at Baseline Minimum Data Set (MDS) information for patient available within 60 days prior to Baseline Informant who is willing to comply with study procedures Exclusion Criteria: Patients who have received NUEDEXTA® in the past 1 year Patients with the diagnosis of Severe Depressive Disorder that would interfere with the conduct of the study Patients who have a history of schizophrenia spectrum and other psychotic disorders Patients with co-existent clinically significant or unstable systemic diseased that could confound the interpretation of the safety results of the study (e.g.,malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) Patients with myasthenia gravis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NUEDEXTA®<br>NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180 | Drug: NUEDEXTA®<br>* NUEDEXTA® only<br>* Other names: dextromethorphan hydrobromide and quinidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Clinical Global Impression of Change (CGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Patient Global Impression of Change (PGIC) Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Number of Participants Using Concomitant Psychotropic Medication | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 
| Scores on the Impact of PBA on Informant Scale | The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PBA, involuntary crying, involuntary laughing