Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

Peripheral Neuropathy Clinical Trial

Official title:

Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524666
• Other study ID #: AgS-001
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2012
• Last updated: February 27, 2018
• Start date: February 2012
• Est. completion date: October 2018

Study information

• Verified date: February 2018
• Source: JFK Medical Center
• Contact: Michael Rosenberg, MD
• Phone: 732-321-7010
• Email: mrosenberg[@]jfkhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Small Fiber Neuropathy

Locations

Country	Name	City	State
United States	JFK Medical Center	Edison	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
JFK Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic Pain Questionnaire		After 2 months
Secondary	QSART & ANSAR testing		After 2 months