PRISM II: An open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

Flora Hammond, David N. Alexander, Andrew J. Cutler, Stephen D'Amico, Rachelle S. Doody, William Sauve, Richard D. Zorowitz, Charles S. Davis, Paul Shin, Fred Ledon, Charles Yonan, Andrea E. Formella, Joao Siffert

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Phase 3 trials supporting dextromethorphan/quinidine (DM/Q) use as a treatment for pseudobulbar affect (PBA) were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). The PRISM II study provides additional DM/Q experience with PBA secondary to dementia, stroke, or traumatic brain injury (TBI). Methods: Participants in this open-label, multicenter, 90-day trial received DM/Q 20/10 mg twice daily. The primary outcome was the Center for Neurologic Study-Lability Scale (CNS-LS), assessing change in PBA episode frequency and severity. The CNS-LS final visit score was compared to baseline (primary analysis) and to the response in a previously conducted placebo-controlled trial with DM/Q in patients with ALS or MS. Secondary outcomes included change in PBA episode count and Clinical Global Impression of Change with respect to PBA as rated by a clinician (CGI-C) and by the patient or caregiver (PGI-C). Results: The study enrolled 367 participants with PBA secondary to dementia, stroke, or TBI. Mean (standard deviation [SD]) CNS-LS score improved significantly from 20.4 (4.4) at baseline to 12.8 (5.0) at Day 90/Final Visit (change, -7.7 [6.1]; P

Original languageEnglish (US)
Article number89
JournalBMC Neurology
Volume16
Issue number1
DOIs
StatePublished - Jun 9 2016

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Dextromethorphan
Quinidine
Dementia
Stroke
Nervous System
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Caregivers
Traumatic Brain Injury
Placebos

Keywords

  • Brain injuries
  • Center for neurologic study-lability scale
  • Dementia
  • Dextromethorphan
  • Neuropsychiatric symptoms
  • Pseudobulbar affect
  • Quinidine
  • Stroke

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

PRISM II : An open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury. / Hammond, Flora; Alexander, David N.; Cutler, Andrew J.; D'Amico, Stephen; Doody, Rachelle S.; Sauve, William; Zorowitz, Richard D.; Davis, Charles S.; Shin, Paul; Ledon, Fred; Yonan, Charles; Formella, Andrea E.; Siffert, Joao.

In: BMC Neurology, Vol. 16, No. 1, 89, 09.06.2016.

Research output: Contribution to journalArticle

Hammond, F, Alexander, DN, Cutler, AJ, D'Amico, S, Doody, RS, Sauve, W, Zorowitz, RD, Davis, CS, Shin, P, Ledon, F, Yonan, C, Formella, AE & Siffert, J 2016, 'PRISM II: An open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury', BMC Neurology, vol. 16, no. 1, 89. https://doi.org/10.1186/s12883-016-0609-0
Hammond, Flora ; Alexander, David N. ; Cutler, Andrew J. ; D'Amico, Stephen ; Doody, Rachelle S. ; Sauve, William ; Zorowitz, Richard D. ; Davis, Charles S. ; Shin, Paul ; Ledon, Fred ; Yonan, Charles ; Formella, Andrea E. ; Siffert, Joao. / PRISM II : An open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury. In: BMC Neurology. 2016 ; Vol. 16, No. 1.
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AU - D'Amico, Stephen

AU - Doody, Rachelle S.

AU - Sauve, William

AU - Zorowitz, Richard D.

AU - Davis, Charles S.

AU - Shin, Paul

AU - Ledon, Fred

AU - Yonan, Charles

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AU - Siffert, Joao

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