Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by JFK Medical Center
Information provided by (Responsible Party):
Dr Charles Porbeni, JFK Medical Center Identifier:
First received: January 31, 2012
Last updated: August 31, 2015
Last verified: August 2015

This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of Arginine) and monitored for two months. Improvement will be noted on their response to the Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by performing autonomic function testing at the beginning and end of the study.

Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

Resource links provided by NLM:

Further study details as provided by JFK Medical Center:

Primary Outcome Measures:
  • Neuropathic Pain Questionnaire [ Time Frame: After 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QSART & ANSAR testing [ Time Frame: After 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Skin Biopsy

Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinic patients at JFK Med CTR


Inclusion Criteria:

  • Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy

Exclusion Criteria:

  • Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy
  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 identifier: NCT01524666

United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 07712
Contact: Karna D Sherwood, M.D.    732-321-7010   
Sponsors and Collaborators
Dr Charles Porbeni
Study Director: Michael Rosenber, M.D. JFK Medical Center
  More Information

Responsible Party: Dr Charles Porbeni, Research Coordinator, JFK Medical Center Identifier: NCT01524666     History of Changes
Other Study ID Numbers: AgS-001
Study First Received: January 31, 2012
Last Updated: August 31, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Vascular Diseases
Vascular Diseases processed this record on October 08, 2015