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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01259050 |
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Date of registration:
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10/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Study of High Doses of Zinc in ALS Patients
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Scientific title:
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Phase 1 Open Label Study of Zinc Therapy in ALS Patients |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01259050 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David S Saperstein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Neurological Associates, LTD |
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Name:
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Todd D Levine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Neurological Associates, LTD |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Zinc and Copper
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Primary Outcome(s)
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To evaluate the safety of high doses of zinc in patients with ALS
[Time Frame: 1 year]
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Secondary Outcome(s)
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Measure levels of BMAA in blood and urine to determine if there is a decline in these levels over the course of treatment
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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