Research Reports - Safety, tolerability, and effectiveness of dextromethorphan for pseudobulbar affect following traumatic brain injury

PM&R
Published: Feb 22, 2018

Flora M. Hammond'Correspondence information about the author Flora M. HammondEmail the author Flora M. Hammond, William Sauve, Fred Ledon, Charles Davis, Andrea E. Formella

Background
Dextromethorphan 20mg /quinidine 10mg (DM/Q) was approved to treat pseudobulbar affect (PBA) based upon phase 3 trials conducted in participants with amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness, safety and tolerability for PBA following stroke, dementia or traumatic brain injury (TBI). Objective. To report results from the TBI cohort of PRISM II, including a TBI-specific functional scale. Design. Open-label trial evaluating twice daily DM/Q over 90 days.

Study participants
Adults (n=120) with a clinical diagnosis of PBA secondary to non-penetrating TBI; stable psychiatric medications were allowed.

Methods
PRISM II was an open-label, 12-week trial enrolling adults with PBA secondary to dementia, stroke, 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. Setting. 150 US centers.

Main Outcome Measurements
Primary endpoint was change in Center for Neurologic Study-Lability Scale (CNS-LS) score from baseline to day 90. Secondary outcomes included PBA episode count, Clinical and Patient Global Impression of Change (CGI-C; PGI-C), Quality of Life-Visual Analog Scale (QOL-VAS), treatment satisfaction, Neurobehavioral Functioning Inventory (NFI), Patient Health Questionnaire (PHQ-9), and Mini Mental State Examination (MMSE).

Results
DM/Q-treated participants showed significant mean (SD) reductions in CNS-LS from baseline (day 30, -5.6 [5.2]; day 90, -8.5 [5.2]; both, P<.001). Compared with baseline, PBA episodes were reduced by 61.3% and 78.5% at days 30 and 90 (both, P<.001). At day 90, 78% and 73% of study participants had “much improved” or “very much improved” on the CGI-C and PGI-C. QOL-VAS scores were significantly reduced from baseline (-3.7 [3.3]; P<.001). Mean (SD) PHQ-9 scores improved compared to baseline at day 30 (-3.2 [5.3], P<.001) and 90 (-5.2 [6.4], P<.001). NFI T-scores were significantly improved (P<.001), while MMSE scores were unchanged. Adverse events (AEs) were consistent with the known DM/Q safety profile; the most common AE was diarrhea (8.3%).

Conclusions
DM/Q was well tolerated and significantly reduced PBA episodes in study participants with TBI. Changes in CNS-LS and PBA episode count were similar to changes with DM/Q in phase 3 trials.

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