Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by JFK Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael Rosenberg, MD, JFK Medical Center
ClinicalTrials.gov Identifier:
NCT01524666
First received: January 31, 2012
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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
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 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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 ClinicalTrials.gov identifier: NCT01524666

Contacts
Contact: Michael Rosenberg, MD 732-321-7010 mrosenberg@jfkhealth.org

Locations
United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 07712
Contact: Michael D Rosenberg, M.D.    732-321-7010    MRosenberg@JFKHealth.org   
Sponsors and Collaborators
JFK Medical Center
Investigators
Principal Investigator: Michael Rosenberg, M.D. JFK Medical Center
  More Information

Publications:
Responsible Party: Michael Rosenberg, MD, MD, JFK Medical Center
ClinicalTrials.gov Identifier: NCT01524666     History of Changes
Other Study ID Numbers: AgS-001 
Study First Received: January 31, 2012
Last Updated: December 1, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Erythromelalgia
Peripheral Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016