Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS - Full Text View

Sponsor:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00021697

Purpose

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: AVP-923	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Quinidine sulfate Quinidine Dextromethorphan hydrochloride Quinidine polygalacturonate Avp 923 Levomethorphan Dextromethorphan Racemethorphan Dextromethorphan hydrobromide Quinidine gluconate

U.S. FDA Resources

Further study details as provided by Avanir Pharmaceuticals:

Estimated Enrollment:	100
Study Start Date:	January 2001
Estimated Study Completion Date:	March 2002

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

18 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021697

Locations

United States, California
Loma Linda University Dept. of Neurology
Loma Linda, California, United States, 92354
UCLA School of Medicine Dept. of Neurology
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Health Sciences
Denver, Colorado, United States, 80262
United States, Florida
University of Miami Dept. of Neurology
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Medical School
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia-Presbyterian Center Neurological Institute
New York, New York, United States, 10032
State University of New York
Syracuse, New York, United States, 13210
United States, North Carolina
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center
Charlotte, North Carolina, United States, 28203
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
MCP-Hahnemann University Dept. of Neurology
Philadelphia, Pennsylvania, United States, 19107
Penn Neurological Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
University of Texas Health Science Center @ San Antonio
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin ALS Clinical Research Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

Additional Information:

Home page of the Muscular Dystrophy Association This link exits the ClinicalTrials.gov site

Sponsor's website This link exits the ClinicalTrials.gov site

Homepage for ALSA/ALS This link exits the ClinicalTrials.gov site

Publications:

Dark FL, McGrath JJ, Ron MA. Pathological laughing and crying. Aust N Z J Psychiatry. 1996 Aug;30(4):472-9. Review.

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.

Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. 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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00021697 History of Changes
Other Study ID Numbers:	99-AVR-102, AVP-923
Study First Received:	August 1, 2001
Last Updated:	August 4, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

AVP-923
Dextromethorphan
Quinidine
Pseudobulbar Affect

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Dextromethorphan
Quinidine
Excitatory Amino Acid Antagonists

Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antimalarials

ClinicalTrials.gov processed this record on February 12, 2012