6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
NUEDEXTA® only
Unnamed facility
Miami, Florida, United States
Unnamed facility
Centerville, Ohio, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 days
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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.
Time frame: 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.
Time frame: 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.
Time frame: 180 days