Safety Study of High Doses of Zinc in ALS Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of Zinc given at 90mg/d in conjunction with 2mg/d of copper in ALS patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Neurological Associates, LTD
• Treatments: Copper; Zinc

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