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Clinical Trial of High Dose CoQ10 in ALS

NCT00243932 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2024-05-07

Study results available
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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.

Conditions

Interventions

DRUG

coenzyme Q10

antioxidant and mitochondrial cofactor, given in capsules three times daily

DRUG

Placebo

Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

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

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00243932 on ClinicalTrials.gov