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Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

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ClinicalTrials.gov Identifier: NCT01524666
Recruitment Status : Unknown
Verified December 2015 by Michael Rosenberg, MD, JFK Medical Center.
Recruitment status was:  Recruiting
First Posted : February 2, 2012
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Small Fiber Neuropathy
Neuromuscular Diseases
Nervous System Diseases