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Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

This study is currently recruiting participants.
Verified December 2015 by Michael Rosenberg, MD, JFK Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524666
First Posted: February 2, 2012
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Rosenberg, MD, JFK Medical Center
  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 Michael Rosenberg, MD, JFK Medical Center:

Primary Outcome Measures:
  • Neuropathic Pain Questionnaire [ Time Frame: After 2 months ]

Secondary Outcome Measures:
  • QSART & ANSAR testing [ Time Frame: After 2 months ]

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

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 Submitted: January 31, 2012
First Posted: February 2, 2012
Last Update Posted: December 2, 2015
Last Verified: December 2015

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


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