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

February 15, 2012
February 17, 2012
March 2012
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01537705 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral 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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Neuropathy
  • Chemotherapy Induced Neuropathy
  • HIV Neuropathy
  • Trauma Induced Neuropathy
Drug: Neuron012703 (Medical Food)
2 capsules twice daily for sixty days.
Experimental: Neuron012703
Amino acid formulation for the dietary management of symptoms related to periphal neuropathy.
Intervention: Drug: Neuron012703 (Medical Food)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Francis Morfin 3232646187 francis_morfin@yahoo.com
Contact: Stephanie Pavlik 3104749809 ext 113 spavlik@ptlcentral.com
United States
 
NCT01537705
012703
No
Targeted Medical Pharma
Targeted Medical Pharma
Not Provided
Principal Investigator: Gabriel Halperin, DPM Gabriel Halperin DPM Inc.
Targeted Medical Pharma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP