Clinical trial NCT02496039: Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
Keywords: PBA
involuntary crying
involuntary laughing
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)
timeFrame: 180 days
measure: Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale
timeFrame: 180 days
measure: Scores on the Clinical Global Impression of Change (CGIC) Scale
timeFrame: 180 days
measure: Scores on the Patient Global Impression of Change (PGIC) Scale
timeFrame: 180 days
measure: Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire
timeFrame: 180 days
measure: Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale
timeFrame: 180 days
measure: Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication
timeFrame: 180 days
measure: Number of Participants Using Concomitant Psychotropic Medication
timeFrame: 180 days
measure: Scores on the Impact of PBA on Informant Scale
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Centerville
country: United States
state: Ohio
Study officials:
References: