Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Neuropathy

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Michael Rosenberg, MD; Phone Number: 732-321-7010; Email: mrosenberg@jfkhealth.org

Study Locations

• United States
  • New Jersey
    • Edison, New Jersey, United States, 07712
      • Recruiting
      • JFK Medical Center
      • Contact: Michael D Rosenberg, M.D.; Phone Number: 732-321-7010; Email: MRosenberg@JFKHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinic patients at JFK Med CTR

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropathic Pain Questionnaire	After 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
QSART & ANSAR testing	After 2 months

Collaborators and Investigators

• Sponsor: JFK Medical Center
• Investigators: Principal Investigator: Michael Rosenberg, M.D., JFK Medical Center

Publications and helpful links

General Publications

• Keynan O, Mirovsky Y, Dekel S, Gilad VH, Gilad GM. Safety and Efficacy of Dietary Agmatine Sulfate in Lumbar Disc-associated Radiculopathy. An Open-label, Dose-escalating Study Followed by a Randomized, Double-blind, Placebo-controlled Trial. Pain Med. 2010 Mar;11(3):356-68. doi: 10.1111/j.1526-4637.2010.00808.x.
• Rosenberg ML, Tohidi V, Sherwood K, Gayen S, Medel R, Gilad GM. Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study. Nutrients. 2020 Feb 23;12(2):576. doi: 10.3390/nu12020576.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Small Fiber Neuropathy
• Other Study ID Numbers: AgS-001