Diabetic Neuropathy Clinical Trial
— Neuron012703Official title:
A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy
A clinical outcomes study measuring reduction in pain and numbness experienced in four types of peripheral neuropathy patients during 60 day administration of the an amino acid formulation.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Confirmation of peripheral neuropathy diagnosis from physician. 2. Subjects able to read and understand English. 3. Subjects willing to commit to all study visits for the duration of administration. 4. Male and non-pregnant/lactating females, ages 18 to 75. Exclusion Criteria: 1. Subjects hospitalized within the last 30 days. 2. History of nerve surgery. 3. Currently taking other medical foods. 4. Existing serious medical condition (i.e. severe heart, liver or kidney disease). 5. Subjects with measured creatinine greater than 2.5, ALT or AST greater than three times normal. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Gabriel Halperin DPM Inc | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Targeted Medical Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS | To measure reduction in pain related to various types of peripheral neuropathy during administration of study intervention using a Visual Analog Scale. | 60 Days | No |
Secondary | NTSS-6 | Neuropathy Total Symptom Score-6 | 60 Days | No |
Secondary | Routine Blood Panel | CBC, Liver panel | 60 days | Yes |
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