Phase 2
Completed N=105
Clinical Trial of High Dose CoQ10 in ALS
Amyotrophic Lateral Sclerosis · Lou Gehrig's Disease
Source: ClinicalTrials.gov NCT00243932 ↗
Enrolled (actual)
105
Serious AEs
25.4%
Results posted
Mar 2011
Primary outcomePrimary: Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score. — 8.80; 9.44; 10.9 units on a scale — p=0.14
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score. |
8.80; 9.44; 10.9 | 0.14 |
| SECONDARY Change in Fatigue Severity Scale |
0.71; 0.88 | — |
| SECONDARY Change in Forced Vital Capacity |
0.20; 0.17 | — |
| SECONDARY Change in Short Form (SF)-36 Score (Physical) |
4.22; 6.04 | — |
| SECONDARY Change in Short Form (SF)-36 Score (Mental) |
2.87; 5.01 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00243932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.