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

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

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

Conditions

Interventions

  • Nuedexta (DM 20 mg/Q 10 mg) Drug
    Other Names: Nuedexta
    Intervention Desc: Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
    ARM 1: Kind: Experimental
    Label: Nuedexta (DM 20 mg/Q 10 mg)
    Description: Open Label - Nuedexta (DM 20 mg/Q 10 mg)

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy endpoint is the mean change from baseline at 12 weeks in CNS-LS score. 12 weeks No
Secondary Safety and Tolerability 12 weeks Yes
Secondary PBA Episode Counts 12 weeks No
Secondary Other Patient Reported Outcomes 12 Weeks No
Secondary Patient Global Impression-Change (PGI-C) 12 Weeks No
Secondary Clinical Global Impression-Change (CGI-C) 12 Weeks No
Secondary Patient Satisfaction with Treatment Survey 12 Weeks No

Sponsors