Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
NCT ID: NCT00573443
Last Updated: 2017-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2007-12-31
2009-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DM 30 mg/Q 10 mg
AVP-923-30/10 Capsules (30 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks
dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
DM 20 mg/ Q 10 mg
AVP-923-20/10 Capsules (20 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks
dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Placebo
Placebo Capsules once daily for 1 week and then twice daily for an additional 11 weeks
Placebo
Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Interventions
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dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 30 mg/ Q 10 mg taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Placebo
Placebo capsules (identical in appearance to AVP-923 capsules being studied in this trial), taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient has a clinical history and clinical relevant symptoms of Pseudobulbar Affect (PBA)
* CNS-LS score at baseline is 13 or greater
Exclusion Criteria
* Any personal history of complete heart block, QTc prolongation, or torsades de pointes
* Any family history of congenital QT interval prolongation syndrome
* Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs (codeine, etc.)
18 Years
80 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Avanir Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Hepner, M.D.
Role: STUDY_DIRECTOR
Avanir Pharmaceuticals
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
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
Neurology Associates
Lincoln, Nebraska, United States
Universitiy of Nevada
Las Vegas, Nevada, United States
Upstate Clinical Research
Albany, New York, United States
Jacobs Neurological Institute
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Neurological Institute - Columbia Presbyterian Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Universitiy Medical Center
Durham, North Carolina, United States
Department of Neurology - The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State Universitiy
Columbus, Ohio, United States
Oregon Health Science University
Portland, Oregon, United States
Drexel University - Department of Neurology
Philadelphia, Pennsylvania, United States
The ALS Center - Penn Neurological Institute - The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
The Methodist Hospital - Baylor College of Medicine
Houston, Texas, United States
Department of Neuropsychiatry - Texas Tech University
Lubbock, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Universitiy of Vermont
Burlington, Vermont, United States
West Virginia University
Morgantown, West Virginia, United States
Dean Foundation
Madison, Wisconsin, United States
FACENE
Buenos Aires, Buenos Aires F.D., Argentina
IADIN
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Italiano
Buenos Aires, Buenos Aires F.D., Argentina
INEBA
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Ramos Mejia
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Britanico
Buenos Aires, Buenos Aires F.D., Argentina
Policlinico Bancario
Buenos Aires, Buenos Aires F.D., Argentina
FLENI
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Militar Regional de Cordoba
Córdoba, Córdoba Province, Argentina
Instituto Medico Rodriguez Alfici
Godoy Cruz, Mendoza Province, Argentina
Instituto de Neurociencias Rosario
Rosario, Santa Fe Province, Argentina
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, M G, Brazil
Hospital de Clínicas-UFPR
Curitiba, Paraná, Brazil
Hospital da Restauração
Recife, Pernambuco, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Pioro EP, Brooks BR, Cummings J, Schiffer R, Thisted RA, Wynn D, Hepner A, Kaye R; Safety, Tolerability, and Efficacy Results Trial of AVP-923 in PBA Investigators. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010 Nov;68(5):693-702. doi: 10.1002/ana.22093.
Other Identifiers
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07-AVR-123
Identifier Type: -
Identifier Source: org_study_id
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