Clinical Trial of High Dose CoQ10 in ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00243932
• Date of registration: 24/10/2005
• Prospective Registration: No
• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: J. L. P. Thompson, Ph.D.
• Affiliation: Director, Statistical Analysis Center, Department of Biostatistics, Mailman School of Public Health (Statistical Principal Investigator)

• Name: Hiroshi Mitsumoto
• Affiliation: Wesley J. Howe Professor of Neurology at the New York Presbyterian Hospital/Columbia University Medical Center

• Name: Petra Kaufmann, MD
• Affiliation: Assistant Professor, Division of Neuromuscular Disease, Columbia University Medical Center (Clinical Principal Investigator)

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

Lou Gehrig's Disease

Amyotrophic Lateral Sclerosis

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)

R01NS048125

AAAA1536

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)

Results

• Results available: Yes
• Date Posted: 17/03/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00243932