Pseudobulbar Affect (Involuntary Laughing and/or Crying)
Conditions
Keywords
PBA, involuntary crying, involuntary laughing
Brief summary
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
Detailed description
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.
Interventions
DRUGNUEDEXTA®
NUEDEXTA® only
Sponsors
Avanir Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) | 180 days | 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. |
| Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale | 180 days | 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. |
| Scores on the Clinical Global Impression of Change (CGIC) Scale | 180 days | 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. |
| Scores on the Patient Global Impression of Change (PGIC) Scale | 180 days | 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. |
| Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire | 180 days | 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. |
| Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale | 180 days | 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. |
| Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication | 180 days | 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. |
| Number of Participants Using Concomitant Psychotropic Medication | 180 days | 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. |
| Scores on the Impact of PBA on Informant Scale | 180 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 14 participants were screened for study enrollment; however, only 5 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate Participants received 20 milligrams (mg) dextromethorphan hydrobromide/10 mg quinidine sulfate capsules administered orally, once a day from Day 1 to Day 7 and twice a day from Day 8 to Day 180. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | 20 mg Dextromethorphan Hydrobromide/10 mg Quinidine Sulfate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
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
Primary
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
Primary
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
Primary
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
Primary
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
Primary
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
Primary
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
Primary
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
Primary
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