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

Background Dextromethorphan (DM) / quinidine (Q) was approved for pseudobulbar affect (PBA) treatment based on efficacy and safety trials in patients with PBA caused by 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. Objective To report results from the stroke cohort of PRISM II, including the Stroke Impact Scale (SIS). Design Open‐label trial evaluating twice‐daily DM/Q over 90 days. Study participants Adults (n = 113) with a clinical diagnosis of PBA secondary to stroke; stable psychiatric medications were allowed. Methods PRISM II was an open‐label, 12‐week trial enrolling adults with PBA caused by dementia, stroke (reported here), or TBI. All study participants received DM/Q 20/10 mg twice daily. Study visits occurred at baseline and at days 30 and 90. Setting 150 U.S. centers. Main Outcome Measurements Primary efficacy measure was changed 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 (MMSE). Results Compared with baseline, CNS‐LS scores (SD) improved by −6.2 (6.1, P