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

Diabetic Neuropathy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diabetic Neuropathy

Chemotherapy Induced Neuropathy

HIV Neuropathy

Trauma Induced Neuropathy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Neuron012703 (Medical Food)2 capsules twice daily for sixty days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Neuron012703Amino acid formulation for the dietary management of symptoms related to periphal neuropathy.

Study Status

Unknown status

Start Date: March 2012

Completed Date: July 2012

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: VAS

Secondary Outcome: NTSS-6

Study sponsors, principal investigator, and references

Principal Investigator: Gabriel Halperin, DPM

Lead Sponsor: Targeted Medical Pharma

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01537705

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