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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT01259050
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-85
2. Male or Female
3. Clinically definite or probable ALS by El Escorial criteria
4. ALS-FRS \> 25
5. If on Riluzole they must be on a stable dose for at least 30 days prior to screening
6. Capable of providing informed consent and complying with trial procedures
Exclusion Criteria:
1. Patients with FVC below 50%
2. History of liver disease
3. Severe renal failure
4. Creatinine greater than or equal to 1.5 mg/dL
5. History of intolerance to zinc or copper
6. Evidence of motor neuron disease for greater than 5 years
7. Any other co-morbid condition which would make completion of the trial unlikely
8. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
9. Any other trial medications. Non-trial medications are not cause for exclusion
10. Patient with history of significant anemia
11. Elevated levels of zinc at baseline
12. Patients with copper levels below normal at baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01259050
Study Brief:
Protocol Section:
NCT01259050