Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis
2 other identifiers
interventional
100
1 country
17
Brief Summary
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2001
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 3, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedJuly 14, 2016
July 1, 2016
1.2 years
August 1, 2001
July 13, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- to 80 years of age, inclusive
- Confirmed diagnosis of ALS or probable ALS
- Clinical history of pseudobulbar affect
- If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study
- If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal
- Must be willing to not take any prohibited medications during participation in the study
You may not qualify if:
- Known sensitivity to quinidine or opiate drugs (codeine, etc.)
- On any anti-depressive medication
- Recently (within two months) diagnosed with ALS
- Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug
- Previously received treatment with co-administration of dextromethorphan and quinidine
- History of substance abuse within the past two years
- Women who are pregnant or likely to become pregnant during the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Loma Linda University Dept. of Neurology
Loma Linda, California, 92354, United States
UCLA School of Medicine Dept. of Neurology
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado Health Sciences
Denver, Colorado, 80262, United States
University of Miami Dept. of Neurology
Miami, Florida, 33136, United States
Northwestern Medical School
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Columbia-Presbyterian Center Neurological Institute
New York, New York, 10032, United States
State University of New York
Syracuse, New York, 13210, United States
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center
Charlotte, North Carolina, 28203, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
MCP-Hahnemann University Dept. of Neurology
Philadelphia, Pennsylvania, 19107, United States
Penn Neurological Institute
Philadelphia, Pennsylvania, 19107, United States
University of Texas Health Science Center @ San Antonio
San Antonio, Texas, 78229, United States
University of Wisconsin ALS Clinical Research Center
Madison, Wisconsin, 53792, United States
Related Publications (9)
Dark FL, McGrath JJ, Ron MA. Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. doi: 10.3109/00048679609065020.
PMID: 8887697BACKGROUNDSmith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995
BACKGROUNDGallagher JP. Pathologic laughter and crying in ALS: a search for their origin. Acta Neurol Scand. 1989 Aug;80(2):114-7. doi: 10.1111/j.1600-0404.1989.tb03851.x.
PMID: 2816272BACKGROUNDWolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. doi: 10.1212/wnl.29.10.1435-b. No abstract available.
PMID: 573397BACKGROUNDMuller U, Murai T, Bauer-Wittmund T, von Cramon DY. Paroxetine versus citalopram treatment of pathological crying after brain injury. Brain Inj. 1999 Oct;13(10):805-11. doi: 10.1080/026990599121197.
PMID: 10576464BACKGROUNDMoore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997 Jul;63(1):89-93. doi: 10.1136/jnnp.63.1.89.
PMID: 9221973BACKGROUNDSchadel M, Wu D, Otton SV, Kalow W, Sellers EM. Pharmacokinetics of dextromethorphan and metabolites in humans: influence of the CYP2D6 phenotype and quinidine inhibition. J Clin Psychopharmacol. 1995 Aug;15(4):263-9. doi: 10.1097/00004714-199508000-00005.
PMID: 7593709BACKGROUNDBrooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE. PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS One. 2013 Aug 21;8(8):e72232. doi: 10.1371/journal.pone.0072232. eCollection 2013.
PMID: 23991068BACKGROUNDBrooks BR, Thisted RA, Appel SH, Bradley WG, Olney RK, Berg JE, Pope LE, Smith RA; AVP-923 ALS Study Group. Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial. Neurology. 2004 Oct 26;63(8):1364-70. doi: 10.1212/01.wnl.0000142042.50528.2f.
PMID: 15505150RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 1, 2001
First Posted
August 3, 2001
Study Start
January 1, 2001
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
July 14, 2016
Record last verified: 2016-07