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

Stroke Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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 PBA in patients with prevalent conditions such as dementia, stroke and traumatic brain injury over a 12 week period.

Clinical Trial 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 CNS Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT01799941
• Study type: Interventional
• Source: Avanir Pharmaceuticals
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 2013
• Completion date: December 2015