Status:
COMPLETED
Safety Study of High Doses of Zinc in ALS Patients
Lead Sponsor:
Phoenix Neurological Associates, LTD
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed with ALS to participate in an open label phase II safety trial with zinc in conjunction with copper, used in c...
Eligibility Criteria
Inclusion
- Age 18-85
- Male or Female
- Clinically definite or probable ALS by El Escorial criteria
- ALS-FRS \> 25
- If on Riluzole they must be on a stable dose for at least 30 days prior to screening
- Capable of providing informed consent and complying with trial procedures
Exclusion
- Patients with FVC below 50%
- History of liver disease
- Severe renal failure
- Creatinine greater than or equal to 1.5 mg/dL
- History of intolerance to zinc or copper
- Evidence of motor neuron disease for greater than 5 years
- Any other co-morbid condition which would make completion of the trial unlikely
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
- Any other trial medications. Non-trial medications are not cause for exclusion
- Patient with history of significant anemia
- Elevated levels of zinc at baseline
- Patients with copper levels below normal at baseline
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01259050
Start Date
October 1 2010
End Date
March 1 2012
Last Update
March 12 2012
Active Locations (1)
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1
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018