Clinical Trial of High Dose CoQ10 in ALS

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease

In brief

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.

Key facts

Study ID

NCT00243932

Run by

Columbia University

People needed

185

Starts

2005-04-01

Expected to finish

2008-03-01

Last updated by the study team

2024-05-07

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Dependency on mechanical ventilation (non-invasive ventilation > 23 hours)
• Severe and unstable concomitant medical or psychiatric illness
• Insufficiently controlled diabetes mellitus
• Concomitant warfarin therapy
• Women who are breast feeding or have a high likelihood of pregnancy
• Significant hepatic dysfunction
• Forced Vital Capacity (FVC) less than 60%
• Exposure to CoQ10 within 30 days of enrollment
• Exposure to other experimental medications within 30 days of enrollment
• Exposure to vitamin E within 14 days of enrollment
• Sensitivity to color additive FD\&C Yellow No. 5
• Sensitivity to aspirin

Where it is running

• University of Arkansas for Medical Sciences, Department of Neurology — Little Rock, Arkansas, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• University of Colorado Health Sciences, Dept of Neurology — Denver, Colorado, United States
• Yale University School of Medicine, Department of Neurology — New Haven, Connecticut, United States
• Northwestern University, Department of Neurology, — Chicago, Illinois, United States
• University of Chicago, Department of Neurology — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky, Dept of Neurology, College of Medicine — Lexington, Kentucky, United States
• Brigham and Women's Hospital , Department of Neurology — Boston, Massachusetts, United States
• Baystate Medical Center, Division of Critical Care Research — Springfield, Massachusetts, United States
• Minneapolis Medical Research Foundation, , — Minneapolis, Minnesota, United States
• Washington University in St. Louis School of Medicine, Department of Neurology — St Louis, Missouri, United States
• Columbia Presbyterian Medical Center, The Neurological Institute — New York, New York, United States
• State University of New York Upstate Medical, Neurology Department — Syracuse, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Drexel University, Dept of Neurology — Philadelphia, Pennsylvania, United States
• University of Texas, Health Science Center at San Antonio, Division of Neurology — San Antonio, Texas, United States
• University of Vermont, Neurology Department — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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