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

Active, not recruiting

Phase 4 Results N/A

Summary of Purpose

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.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 18 December 2015.

1 Feb 2013 25 Feb 2013 1 Jun 2015 1 Dec 2015 1 Feb 2015 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

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


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