NCT01799941

Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)

A Study to Assess the Safety, Tolerability and Effectiveness of Nuedexta (Dextromethorphan 20 mg/Quinidine 10 mg) in the Treatment of Pseudobulbar Affect (PBA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.

Detailed description

This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks. Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study. The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.

Conditions

• Pseudobulbar Affect (PBA)
• Stroke
• Dementia
• Traumatic Brain Injury (TBI)

Interventions

Type	Name	Description
DRUG	Nuedexta (DM 20 mg/Q 10 mg)	Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-02-27
• Last updated: 2017-03-15
• Results posted: 2017-03-15

Locations

1 site across 1 country: United States