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

Phase 4

Terminated

• Conditions: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
• Interventions: Drug: NUEDEXTA®

• Registration Number: NCT02496039
• Lead Sponsor: Avanir Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-04-18
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Results First Posted: 2017-07-03
• Last Update Posted: 2017-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NUEDEXTA®	NUEDEXTA®	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

Primary Outcome Measures

Name	Time	Method
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.
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 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 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.
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.
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 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.