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

NCT02496039 | Terminated Phase 4 Results

• 1 other identifier: 15-AVR-404
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Keywords

PBA; involuntary crying; involuntary laughing

Outcome Measures

Primary Outcomes (9)

• Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)

  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.

  180 days

• Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale

  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.

  180 days

• Scores on the Clinical Global Impression of Change (CGIC) Scale

  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.

  180 days

• Scores on the Patient Global Impression of Change (PGIC) Scale

  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.

  180 days

• Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire

  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.

  180 days

• Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale

  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.

  180 days

• Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication

  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.

  180 days

• Number of Participants Using Concomitant Psychotropic Medication

  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.

  180 days

• Scores on the Impact of PBA on Informant Scale

  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.

  180 days

Study Arms (1)

NUEDEXTA®

OTHER

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®

Interventions

NUEDEXTA® DRUG

NUEDEXTA® only

Also known as: dextromethorphan hydrobromide and quinidine

NUEDEXTA®

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Miami, Florida, 33137, United States

Location

Unknown Facility

Centerville, Ohio, 45459, United States

Location

MeSH Terms

Interventions

dextromethorphan - quinidine combination; Dextromethorphan; Quinidine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cinchona Alkaloids; Quinuclidines; Quinolines; Heterocyclic Compounds, 2-Ring

Limitations and Caveats

The study was terminated prematurely because of difficulty with recruiting.

Results Point of Contact

• Title: Nadine Knowles; Executive Director, Research & Development Operations
• Organization: Avanir Pharmaceuticals

nknowles@avanir.com

1-949-268-8972

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 3, 2017
• Results First Posted: July 3, 2017

Record last verified: 2017-06

Locations

US (2)