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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

NUEDEXTA®

Intervention Type DRUG

NUEDEXTA® only

Interventions

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NUEDEXTA®

NUEDEXTA® only

Intervention Type DRUG

Other Intervention Names

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dextromethorphan hydrobromide and quinidine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No