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

Phase 3

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00021697
• Lead Sponsor: Avanir Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2001-08-01
• Study First Submitted QC: 2001-08-02
• Study First Posted: 2001-08-03
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (17)

Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center; 🇺🇸 Charlotte, North Carolina, United States

University of Wisconsin ALS Clinical Research Center; 🇺🇸 Madison, Wisconsin, United States

Columbia-Presbyterian Center Neurological Institute; 🇺🇸 New York, New York, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Loma Linda University Dept. of Neurology; 🇺🇸 Loma Linda, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

UCLA School of Medicine Dept. of Neurology; 🇺🇸 Los Angeles, California, United States

University of Miami Dept. of Neurology; 🇺🇸 Miami, Florida, United States

Northwestern Medical School; 🇺🇸 Chicago, Illinois, United States

University of Colorado Health Sciences; 🇺🇸 Denver, Colorado, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

State University of New York; 🇺🇸 Syracuse, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Texas Health Science Center @ San Antonio; 🇺🇸 San Antonio, Texas, United States

MCP-Hahnemann University Dept. of Neurology; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Neurological Institute; 🇺🇸 Philadelphia, Pennsylvania, United States