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 recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Targeted Medical Pharma.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01537705
First received: February 15, 2012
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Diabetic Neuropathy
Chemotherapy Induced Neuropathy
HIV Neuropathy
Trauma Induced Neuropathy
Drug: Neuron012703 (Medical Food)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • VAS [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    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:
  • NTSS-6 [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    Neuropathy Total Symptom Score-6

  • Routine Blood Panel [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    CBC, Liver panel


Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537705

Contacts
Contact: Francis Morfin 3232646187 francis_morfin@yahoo.com
Contact: Stephanie Pavlik 3104749809 ext 113 spavlik@ptlcentral.com

Locations
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
Investigators
Principal Investigator: Gabriel Halperin, DPM Gabriel Halperin DPM Inc.
  More Information

No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01537705     History of Changes
Other Study ID Numbers: 012703
Study First Received: February 15, 2012
Last Updated: February 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Targeted Medical Pharma:
Medical food
Neuropathy
Diabetes
Neuropathic Pain

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

ClinicalTrials.gov processed this record on September 16, 2014