Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01537705
Other study ID # 012703
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received February 15, 2012
Last updated February 17, 2012
Start date March 2012
Est. completion date July 2012

Study information

Verified date February 2012
Source Targeted Medical Pharma
Contact Francis Morfin
Phone 3232646187
Email francis_morfin@yahoo.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Neuron012703 (Medical Food)
2 capsules twice daily for sixty days.

Locations

Country Name City State
United States Gabriel Halperin DPM Inc Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Targeted Medical Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS To measure reduction in pain related to various types of peripheral neuropathy during administration of study intervention using a Visual Analog Scale. 60 Days No
Secondary NTSS-6 Neuropathy Total Symptom Score-6 60 Days No
Secondary Routine Blood Panel CBC, Liver panel 60 days Yes
See also
  Status Clinical Trial Phase
Completed NCT04025320 - The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy N/A
Completed NCT02659007 - Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga Phase 1
Completed NCT01953757 - A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2) N/A
Completed NCT01707979 - NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes N/A
Completed NCT00608439 - Centella Asiatica Selected Triterpenes (CAST) for Diabetic Neuropathy Phase 2
Completed NCT00576277 - Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain Phase 1/Phase 2
Completed NCT00830011 - Cognitive Behavioral Therapy for Painful Diabetic Neuropathy N/A
Completed NCT00235443 - A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy Phase 2/Phase 3
Completed NCT00931879 - Lovaza® and Microvascular Function in Type 2 Diabetes Phase 4
Completed NCT00190970 - The Effect of Ruboxistaurin on Small Fiber Function Phase 2
Completed NCT00101426 - Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy Phase 3
Completed NCT00238550 - Study of CBME in the Relief of Painful Diabetic Neuropathy Phase 2
Completed NCT05573685 - Basket Study (CT-100-002) to Evaluate the Effects of a DiNaMo™ Component Training N/A
Recruiting NCT02341261 - Activity for Diabetic Polyneuropathy N/A
Completed NCT01822925 - Study of DA-9801 to Treat Diabetic Neuropathy Phase 2
Completed NCT01690962 - A Nutritional Intervention for Diabetic Neuropathy N/A
Terminated NCT00993018 - A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy Phase 2
Withdrawn NCT02315235 - The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy N/A
Completed NCT00496457 - Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy Phase 2
Recruiting NCT02606747 - The Balance Control Mechanism of DPN Patients N/A