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Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS Clinical research trials and Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS. Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS  Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
For Condition: Amyotrophic Lateral Sclerosis
Status: Completed
Sponsor(s): Avanir Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 100
Location and Contact Information:
Wake Forest University
Winston Salem, North Carolina, 27157
United States
Penn Neurological Institute
Philadelphia, Pennsylvania, 19107
United States
Carolinas Medical Center Carolinas Neuromuscular/ALS-MDA Center
Charlotte, North Carolina, 28203
United States
State University of New York
Syracuse, New York, 13210
United States
University of Texas Health Science Center @ San Antonio
San Antonio, Texas, 78229
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Colorado Health Sciences
Denver, Colorado, 80262
United States
Loma Linda University Dept. of Neurology
Loma Linda, California, 92354
United States
Columbia-Presbyterian Center Neurological Institute
New York City, New York, 10032
United States
Northwestern Medical School
Chicago, Illinois, 60611
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
University of Miami Dept. of Neurology
Miami, Florida, 33136
United States
UCLA School of Medicine Dept. of Neurology
Los Angeles, California, 90095
United States
University of Wisconsin ALS Clinical Research Center
Madison, Wisconsin, 53792
United States
MCP-Hahnemann University Dept. of Neurology
Philadelphia, Pennsylvania, 19107
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Additional Information:
Study ID Numbers: 99-AVR-102; AVP-923
Study Start Date: January 2001
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021697
Other Amyotrophic Lateral Sclerosis Studies:
1. Clinical trial of creatine in amyotrophic lateral sclerosis [ALS]
2. Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)
3. Creatine for the Treatment of Amyotrophic Lateral Sclerosis
4. IGF-1/ALS Trial
5. Determinants of Disease Severity in Amyotrophic Lateral Sclerosis
Related Studies:
Other Amyotrophic Lateral Sclerosis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
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