title: An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results.
abstract: Dextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to dementia, stroke, or traumatic brain injury; dementia cohort results are reported.
  
  
  
  This was an open-label, multicenter, 90 day trial; patients received DM/Q 20/10 mg twice daily. Primary outcome was change in Center for Neurologic Study-Lability Scale (CNS-LS) score. Secondary outcomes included PBA episode count and Clinical and Patient/Caregiver Global Impression of Change scores with respect to PBA (CGI-C/PGI-C).
  
  
  
  134 patients were treated. CNS-LS improved by a mean (SD) of 7.2 (6.0) points at Day 90/Endpoint (P<.001) vs. baseline. PBA episodes were reduced 67.7% (P<.001) vs. baseline; global measures showed 77.5% CGI-C and 76.5% PGI-C "much"/"very much" improved. Adverse events included headache (7.5%), urinary tract infection (4.5%), and diarrhea (3.7%); few patients dropped out for adverse events (10.4%).
  
  
  
  DM/Q significantly reduced PBA symptoms in patients with dementia; reported adverse events were consistent with the known safety profile of DM/Q. Trial Registration clinicaltrials.gov identifier: NCT01799941.
authors.affiliation: Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Rachelle S
authors.initials: RS
authors.lastname: Doody
authors.affiliation: Cornerstone Medical Group, Franklin, Tennessee, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: D'Amico
authors.affiliation: Florida Clinical Research Center, LLC, Bradenton, Florida, USA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Cutler
authors.affiliation: CSD Biostatistics, Inc., Tucson, Arizona, USA.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Davis
authors.affiliation: Avanir Pharmaceuticals, Inc., Aliso Viejo, California, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Shin
authors.affiliation: Avanir Pharmaceuticals, Inc., Aliso Viejo, California, USA.
authors.forename: Fred
authors.initials: F
authors.lastname: Ledon
authors.affiliation: Avanir Pharmaceuticals, Inc., Aliso Viejo, California, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Yonan
authors.affiliation: Avanir Pharmaceuticals, Inc., Aliso Viejo, California, USA.
authors.forename: João
authors.initials: J
authors.lastname: Siffert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications; D003704:Dementia / Q000150:complications*; D015140:Dementia, Vascular / Q000150:complications; D003915:Dextromethorphan / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004338:Drug Combinations; D018691:Excitatory Amino Acid Antagonists / Q000627:therapeutic use*; D005260:Female; D057180:Frontotemporal Dementia / Q000150:complications; D006261:Headache / Q000139:chemically induced; D006801:Humans; D020961:Lewy Body Disease / Q000150:complications; D008297:Male; D008875:Middle Aged; D020828:Pseudobulbar Palsy / Q000188:drug therapy* / Q000209:etiology; D011802:Quinidine / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000139:chemically induced
chemical_list: D004338:Drug Combinations; D018691:Excitatory Amino Acid Antagonists; C507057:dextromethorphan - quinidine combination; D003915:Dextromethorphan; D011802:Quinidine
keywords: Aged; Center for Neurologic Study–Lability Scale; dementia; dextromethorphan; global impression of change; neuropsychiatric symptoms; pseudobulbar affect; quinidine