Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
NCT ID: NCT00021697
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2001-01-31
2002-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS
NCT00573443
Dextromethorphan to Treat Patients With Voice Spasms
NCT00055549
Phase 3 Study of Dexpramipexole in ALS
NCT01281189
Impact of Nuedexta on Bulbar Physiology and Function in ALS
NCT03883581
A Phase 2 RCT Study of CX-8998 for Essential Tremor
NCT03101241
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AVP-923
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion:
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avanir Pharmaceuticals
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loma Linda University Dept. of Neurology
Loma Linda, California, United States
UCLA School of Medicine Dept. of Neurology
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Health Sciences
Denver, Colorado, United States
University of Miami Dept. of Neurology
Miami, Florida, United States
Northwestern Medical School
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Columbia-Presbyterian Center Neurological Institute
New York, New York, United States
State University of New York
Syracuse, New York, United States
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center
Charlotte, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MCP-Hahnemann University Dept. of Neurology
Philadelphia, Pennsylvania, United States
Penn Neurological Institute
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center @ San Antonio
San Antonio, Texas, United States
University of Wisconsin ALS Clinical Research Center
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995
Gallagher 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.
Wolf 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.
Muller 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.
Moore 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.
Schadel 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.
Brooks 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.
Brooks 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.
Related Links
Access external resources that provide additional context or updates about the study.
Homepage for ALSA/ALS
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AVP-923
Identifier Type: -
Identifier Source: secondary_id
99-AVR-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.