COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524666
Recruitment Status : Unknown
Verified February 2018 by Michael Rosenberg, MD, JFK Medical Center.
Recruitment status was:  Recruiting
First Posted : February 2, 2012
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Michael Rosenberg, MD, JFK Medical Center

Brief Summary:
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.

Condition or disease
Peripheral Neuropathy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
Study Start Date : February 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Primary Outcome Measures :
  1. Neuropathic Pain Questionnaire [ Time Frame: After 2 months ]

Secondary Outcome Measures :
  1. QSART & ANSAR testing [ Time Frame: After 2 months ]

Biospecimen Retention:   Samples Without DNA
Skin Biopsy

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524666

Layout table for location contacts
Contact: Michael Rosenberg, MD 732-321-7010

Layout table for location information
United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 07712
Contact: Michael D Rosenberg, M.D.    732-321-7010   
Sponsors and Collaborators
JFK Medical Center
Layout table for investigator information
Principal Investigator: Michael Rosenberg, M.D. JFK Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Rosenberg, MD, MD, JFK Medical Center Identifier: NCT01524666    
Other Study ID Numbers: AgS-001
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Small Fiber Neuropathy
Neuromuscular Diseases
Nervous System Diseases