NCT02496039

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pseudobulbar Affect (Involuntary Laughing and/or Crying)

Interventions

Type	Name	Description
DRUG	NUEDEXTA®	NUEDEXTA® only

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-07-14
• Last updated: 2017-07-03
• Results posted: 2017-07-03

Locations

2 sites across 1 country: United States