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

Avanir Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Treatments: Drug: NUEDEXTA®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02496039

15-AVR-404

Details and patient eligibility

About

6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

NUEDEXTA®

Other group

Description:

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

Treatment:

Drug: NUEDEXTA®