Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedFebruary 28, 2018
February 1, 2018
6.7 years
January 31, 2012
February 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Neuropathic Pain Questionnaire
After 2 months
Secondary Outcomes (1)
QSART & ANSAR testing
After 2 months
Eligibility Criteria
Clinic patients at JFK Med CTR
You may qualify if:
- Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy
You may not qualify if:
- Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JFK Medical Center
Edison, New Jersey, 07712, United States
Related Publications (2)
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.
PMID: 20447305BACKGROUNDRosenberg 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.
PMID: 32102167DERIVED
Biospecimen
Skin Biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Rosenberg, M.D.
JFK Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 2, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
February 28, 2018
Record last verified: 2018-02