Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01537705
Status:
UNKNOWN
Last Update Posted:
2012-02-23
First Post:
2012-02-15
Brief 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
Sponsor:
Targeted Medical Pharma
Organization:
Targeted Medical Pharma
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neuron012703
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 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 neuropathys 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 35 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None