Clinical Trial of High Dose CoQ10 in ALS

Status: Completed
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: No
View:

• Clinical diagnosis of definite, probable, or laboratory-supported probable ALS

• Negative pregnancy test for women of childbearing age and adequate birth control measures

• Subjects must be able and willing to give informed consent and must be capable of complying with the trial procedures

• Forced Vital Capacity (FVC) >/= 60% of predicted

• Age 21 to 85 years, inclusive

• Disease duration of less than 5 years

• Subjects may take riluzole (without change in dose for more than 30 days before enrollment)

• Patients who have taken CoQ10 in the past will be eligible if they stop at least 30 days before enrollment

• Patients who have taken vitamin E in the past will be eligible if they stop at least 14 days before enrollment

Locations
United States
Arkansas
University of Arkansas for Medical Sciences, Department of Neurology
Little Rock
California
California Pacific Medical Center
San Francisco
University of California at San Francisco
San Francisco
Colorado
University of Colorado Health Sciences, Dept of Neurology
Denver
Connecticut
Yale University School of Medicine, Department of Neurology
New Haven
Illinois
Northwestern University, Department of Neurology,
Chicago
University of Chicago, Department of Neurology
Chicago
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky, Dept of Neurology, College of Medicine
Lexington
Massachusetts
Brigham and Women's Hospital , Department of Neurology
Boston
Baystate Medical Center, Division of Critical Care Research
Springfield,
Minnesota
Minneapolis Medical Research Foundation, ,
Minneapolis
Missouri
Washington University in St. Louis School of Medicine, Department of Neurology
St. Louis
New York
Columbia Presbyterian Medical Center, The Neurological Institute
New York
State University of New York Upstate Medical, Neurology Department
Syracuse
Ohio
Cleveland Clinic Foundation
Cleveland
Pennsylvania
Drexel University, Dept of Neurology
Philadelphia
Texas
University of Texas, Health Science Center at San Antonio, Division of Neurology
San Antonio
Vermont
University of Vermont, Neurology Department
Burlington
Time Frame
Start Date: April 2005
Completion Date: March 2008
Participants
Target number of participants: 185
Treatments
Experimental: 2,700 mg CoQ10
Placebo Comparator: placebo
Experimental: 1,800 mg CoQ10
Authors
Hiroshi Mitsumoto, Petra Kaufmann, J. L. P. Thompson
Sponsors
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Columbia University

This content was sourced from clinicaltrials.gov

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