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Sponsored by: |
Avanir Pharmaceuticals |
Information provided by: | Avanir Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00021697 |
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 |
Genetics Home Reference related topics: | amyotrophic lateral sclerosis |
MedlinePlus related topics: | Amyotrophic Lateral Sclerosis |
ChemIDplus related topics: | Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan Quinidine Avp 923 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
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 | |||||
Wake Forest University | |||||
Winston Salem, North Carolina, United States, 27157 | |||||
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center | |||||
Charlotte, North Carolina, United States, 28203 | |||||
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 |
Avanir Pharmaceuticals |
Home page of the Muscular Dystrophy Association 
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Sponsor's website 
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Homepage for ALSA/ALS 
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Study ID Numbers: | 99-AVR-102, AVP-923 |
First Received: | August 1, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00021697 |
Health Authority: | United States: Food and Drug Administration |
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