A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy (Neuron012703)

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Neuropathy; Chemotherapy Induced Neuropathy; HIV Neuropathy; Trauma Induced Neuropathy
• Intervention / Treatment: Drug: Neuron012703 (Medical Food)

Detailed Description

Peripheral neuropathy is a disorder of the peripheral nerves-the motor, sensory and autonomic nerves that connect the spinal cord to muscles, skin and internal organs. It usually affects the hands and feet, causing weakness, numbness, tingling and pain. Peripheral neuropathy's course is variable; it can come and go, slowly progressing over many years, or it can become severe and debilitating. Peripheral neuropathy is common and it is estimated that upwards of 20 million Americans suffer from this illness. It can occur at any age, but is more common among elderly patients. In l999, a survey found that 8-9% of Medicare recipients have peripheral neuropathy as their primary or secondary diagnosis and the annual cost to Medicare exceeds $3.5 billion. Approximately 30% of peripheral neuropathy cases are linked to diabetes. Other common causes of neuropathy include autoimmune disorders, tumors, hereditary conditions, nutritional imbalances, infections or toxins. Another 30% of peripheral neuropathies are termed "idiopathic" when the cause is unknown. Pain in particular is a complex process initiated by pain-inducing or noxious stimuli interacting with pain receptors (nociceptors) which triggers a series of action potentials that are transmitted by neurotransmitters from peripheral afferent neurons to the spinal cord and higher nerve centers in the brain.

The study intervention is classified as a medical food that must be used under the active or ongoing supervision of a physician. Medical foods are developed to address the different or altered physiologic requirements that may exist for individuals with distinctive nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth associated with inflammation and other medical conditions, as well as from pharmaceutical therapies. All of the ingredients included in the study intervention are classified as generally recognized as safe (GRAS) by the United States Food and Drug Administration (FDA). To qualify for GRAS status, a substance that is added to a food, including a medical food, has to be supported by data demonstrating that it is safe when consumed in amounts from these foods, as they are typically ingested or prescribed.

The study intervention is a proprietary blend of amino acids and antioxidants designed to target the cellular processes involved in the management of peripheral neuropathy symptoms. All of the ingredients are supplied in small milligram quantities which allows for safe and flexible dosing.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Francis Morfin; Phone Number: 3232646187; Email: francis_morfin@yahoo.com
• Study Contact Backup: Name: Stephanie Pavlik; Phone Number: 113 3104749809; Email: spavlik@ptlcentral.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90063
      • Gabriel Halperin DPM Inc
      • Contact: Francis Morfin; Phone Number: 323-264-6187

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuron012703; Amino acid formulation for the dietary management of symptoms related to periphal neuropathy.	Drug: Neuron012703 (Medical Food); 2 capsules twice daily for sixty days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NTSS-6	Neuropathy Total Symptom Score-6	60 Days
Routine Blood Panel	CBC, Liver panel	60 days

Collaborators and Investigators

• Sponsor: Targeted Medical Pharma
• Investigators: Principal Investigator: Gabriel Halperin, DPM, Gabriel Halperin DPM Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): February 23, 2012
• Last Update Submitted That Met QC Criteria: February 17, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes; Neuropathy; Neuropathic Pain; Medical food
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: 012703