Safety Study of High Doses of Zinc in ALS Patients

Completed · Phase 1/Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT01259050

Run by

Phoenix Neurological Associates, LTD

People needed

10

Starts

2010-10-01

Expected to finish

2012-03-01

Last updated by the study team

2012-03-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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