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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00243932
Date of registration: 24/10/2005
Prospective Registration: Yes
Primary sponsor: Columbia University
Public title: Clinical Trial of High Dose CoQ10 in ALS
Scientific title: Clinical Trial of High Dose CoQ10 in ALS
Date of first enrolment: April 2005
Target sample size: 185
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00243932
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Petra Kaufmann, MD
Address: 
Telephone:
Email:
Affiliation:  Assistant Professor, Division of Neuromuscular Disease, Columbia University Medical Center (Clinical Principal Investigator)
Name:     J. L. P. Thompson, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Director, Statistical Analysis Center, Department of Biostatistics, Mailman School of Public Health (Statistical Principal Investigator)
Name:     Hiroshi Mitsumoto
Address: 
Telephone:
Email:
Affiliation:  Wesley J. Howe Professor of Neurology at the New York Presbyterian Hospital/Columbia University Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 21 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Lou Gehrig's Disease
Intervention(s)
Drug: coenzyme Q10
Drug: Placebo
Primary Outcome(s)
Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score. [Time Frame: 9 months]
Secondary Outcome(s)
The Change Over 9 Months in Forced Vital Capacity; Fatigue Severity Scale; Short Form-36; and 8OH2dG (a Biomarker of Oxidative Stress Measured in a Blood Sample). [Time Frame: 9 months]
Secondary ID(s)
AAAA1536
R01NS048125
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
Ethics review
Results
Results available: Yes
Date Posted: 17/03/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00243932
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