Clinical Trial: 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 Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:

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 intervent
Sponsor: Targeted Medical Pharma

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NTSS-6 [ Time Frame: 60 Days ]
    Neuropathy Total Symptom Score-6
  • Routine Blood Panel [ Time Frame: 60 days ]
    CBC, Liver panel


Original Secondary Outcome: Same as current

Information By: Targeted Medical Pharma

Dates:
Date Received: February 15, 2012
Date Started: March 2012
Date Completion: July 2012
Last Updated: February 17, 2012
Last Verified: February 2012