Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT00243932
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00243932
Study Brief:
Protocol Section:
NCT00243932