CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 185 enrolled
Drug / intervention
coenzyme Q10 +1 moredrug
Likely dose
Coenzyme Q10 in capsules three times dailyAI-extracted
Key inclusion· 6
  • ✓Clinical diagnosis of definite, probable, or laboratory-supported probable ALS
  • ✓Age 21 to 85 years, inclusive
  • ✓Forced Vital Capacity (FVC) ≥60% of predicted
  • ✓Disease duration less than 5 years
Key exclusion· 11
  • ✕Dependency on mechanical ventilation (non-invasive ventilation >23 hours daily)
  • ✕Forced Vital Capacity (FVC) less than 60%
  • ✕Severe and unstable concomitant medical or psychiatric illness
  • ✕Insufficiently controlled diabetes mellitus

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00243932
NCT00243932Phase 2Completed
CompareCT.gov

Clinical Trial of High Dose CoQ10 in ALS

Columbia University·interventional·Posted Oct 25, 2005·Updated May 7, 2024

In Brief

A Phase 2 clinical trial evaluating coenzyme Q10 and Placebo for Amyotrophic Lateral Sclerosis and Lou Gehrig's Disease. Completed, enrolled 185 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis, Lou Gehrig's Disease
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2005
Enrollment StartApr 1, 2005
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.7 years ago

Interventions

coenzyme Q10drug

antioxidant and mitochondrial cofactor, given in capsules three times daily

Placebodrug

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