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

This study has been completed.
Information provided by:
Avanir Pharmaceuticals Identifier:
First received: August 1, 2001
Last updated: July 13, 2016
Last verified: July 2016
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Avanir Pharmaceuticals:

Estimated Enrollment: 100
Study Start Date: January 2001
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00021697

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:
Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995 Identifier: NCT00021697     History of Changes
Other Study ID Numbers: 99-AVR-102
Study First Received: August 1, 2001
Last Updated: July 13, 2016

Keywords provided by Avanir Pharmaceuticals:
Pseudobulbar Affect

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors processed this record on April 28, 2017