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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.
Sponsor:
Information provided by:
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00021697
First received: August 1, 2001
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  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 3

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:

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:
Smith RA, Moore SR, Gresham LS, Manley PE, Licht JM: The treatment of affective lability with dextromethorphan. Neurology 54: 604P, 1995

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 May 23, 2013