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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01537705
Recruitment Status : Unknown
Verified February 2012 by Targeted Medical Pharma.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2012
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):
Targeted Medical Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Chemotherapy Induced Neuropathy HIV Neuropathy Trauma Induced Neuropathy Drug: Neuron012703 (Medical Food) Phase 2

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. VAS [ Time Frame: 60 Days ]
    To measure reduction in pain related to various types of peripheral neuropathy during administration of study intervention using a Visual Analog Scale.

Secondary Outcome Measures :
  1. NTSS-6 [ Time Frame: 60 Days ]
    Neuropathy Total Symptom Score-6

  2. Routine Blood Panel [ Time Frame: 60 days ]
    CBC, Liver panel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01537705

Contact: Francis Morfin 3232646187
Contact: Stephanie Pavlik 3104749809 ext 113

United States, California
Gabriel Halperin DPM Inc Not yet recruiting
Los Angeles, California, United States, 90063
Contact: Francis Morfin    323-264-6187      
Sponsors and Collaborators
Targeted Medical Pharma
Principal Investigator: Gabriel Halperin, DPM Gabriel Halperin DPM Inc.

Responsible Party: Targeted Medical Pharma Identifier: NCT01537705     History of Changes
Other Study ID Numbers: 012703
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Targeted Medical Pharma:
Medical food
Neuropathic Pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases