Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
Completed · Phase 3 · Has a placebo group
Conditions studied: Pseudobulbar Affect (PBA)
In brief
Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-30\] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-20\]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.
Key facts
- Study ID
- NCT00573443
- Run by
- Avanir Pharmaceuticals
- People needed
- 326
- Starts
- 2007-12-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2017-04-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Neuromuscular Research Center — Scottsdale, Arizona, United States
- South Coast Clinical Trials — Anaheim, California, United States
- UCI Medical Center — Irvine, California, United States
- Center for Neurologic Study — La Jolla, California, United States
- UCLA School of Medicine — Los Angeles, California, United States
- The Forbes Norris MDA/ALS Research Center - California Pacific Medical Center — San Francisco, California, United States
- The ALS Center at UCSF — San Francisco, California, United States
- University of Colorado at Denver & Health Science Center — Aurora, Colorado, United States
- Neuroscience Center — Fort Lauderdale, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Suncoast Neuroscience Associates — St. Petersburg, Florida, United States
- The ALS Center at Emory University — Atlanta, Georgia, United States
- Neurology Specialists of Decatur of Decatur — Decatur, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Consultants in Neurology — Northbrook, Illinois, United States
- University of Kentucky Health Care - Dept. of Neurology — Lexington, Kentucky, United States
- The John Hopkins Universitiy — Baltimore, Maryland, United States
- Massachusets General Hospital — Boston, Massachusetts, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- St.Louis University - Neuromuscular Clinic — St Louis, Missouri, United States
- Advanced Neurology Specialists — Great Falls, Montana, United States
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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