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

• ClinicalTrials.gov Identifier: NCT02496039
• Recruitment Status: Terminated
• First Posted: July 14, 2015
• Results First Posted: July 3, 2017
• Last Update Posted: July 3, 2017
• Sponsor: Avanir Pharmaceuticals
• Information provided by (Responsible Party): Avanir Pharmaceuticals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pseudobulbar Affect (Involuntary Laughing and/or Crying)	Drug: NUEDEXTA®	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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 Start Date: September 2015
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
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	Drug: NUEDEXTA®; NUEDEXTA® only; Other Name: dextromethorphan hydrobromide and quinidine

Outcome Measures

Primary Outcome Measures :

1. Scores on the Center for Neurologic Study-Lability Scale (CNS-LS) [ Time Frame: 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.
2. Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale [ Time Frame: 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.
3. Scores on the Clinical Global Impression of Change (CGIC) Scale [ Time Frame: 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.
4. Scores on the Patient Global Impression of Change (PGIC) Scale [ Time Frame: 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.
5. Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire [ Time Frame: 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.
6. Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale [ Time Frame: 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.
7. Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication [ Time Frame: 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.
8. Number of Participants Using Concomitant Psychotropic Medication [ Time Frame: 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.
9. Scores on the Impact of PBA on Informant Scale [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Miami, Florida, United States, 33137

United States, Ohio

Centerville, Ohio, United States, 45459

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

• Responsible Party: Avanir Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02496039
• Other Study ID Numbers: 15-AVR-404
• First Posted: July 14, 2015
• Results First Posted: July 3, 2017
• Last Update Posted: July 3, 2017
• Last Verified: June 2017

Keywords provided by Avanir Pharmaceuticals:

PBA; involuntary crying; involuntary laughing

Additional relevant MeSH terms:

Quinidine; Dextromethorphan; Antitussive Agents; Respiratory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Anti-Arrhythmia Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors