A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Targeted Medical Pharma

Criteria

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.