Dextromethorphan/Quinidine for Pseudobulbar Affect Following Stroke: Safety and Effectiveness in the PRISM II Trial

Publication date: Available online 30 June 2018Source: PM&RAuthor(s): Richard D. Zorowitz, David N. Alexander, Andrea E. Formella, Fred Ledon, Charles Davis, Joao SiffertAbstractBackgroundDextromethorphan (DM)/quinidine (Q) was approved for pseudobulbar affect (PBA) treatment based upon efficacy and safety trials in patients with PBA secondary to amyotrophic lateral sclerosis or multiple sclerosis. The PRISM II trial evaluated DM/Q as PBA treatment in patients with stroke, dementia or traumatic brain injury.ObjectiveTo report results from the stroke cohort of PRISM II, including the Stroke Impact Scale (SIS).DesignOpen-label trial evaluating twice daily DM/Q over 90 daysStudy participantsAdults (n=113) with a clinical diagnosis of PBA secondary to stroke; stable psychiatric medications were allowed.MethodsPRISM II was an open-label, 12-week trial enrolling adults with PBA secondary to dementia, stroke (reported here), or TBI. All study participants received DM/Q 20/10 mg twice daily. Study visits occurred at baseline and at day 30 and day 90.Setting150 US centers.Main Outcome MeasurementsPrimary efficacy measure was change from baseline to day 90 in Center for Neurologic Study-Lability Scale (CNS-LS) scores. Secondary outcomes included PBA episodes (estimated over 7 days), Clinical and Patient/Caregiver Global Impression of Change (CGI-C and PGI-C), Quality of Life-Visual Analog Scale (QOL-VAS), SIS, Patient Health Questionnaire (PHQ-9), and Mini-Mental State Examination (MMS...
Source: PMandR - Category: Rehabilitation Source Type: research

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