Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by JFK Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Charles Porbeni, JFK Medical Center
ClinicalTrials.gov Identifier:
NCT01524666
First received: January 31, 2012
Last updated: April 10, 2012
Last verified: February 2012
  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: July 2012
Estimated Primary Completion Date: May 2012 (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

Locations
United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 07712
Contact: Karna D Sherwood, M.D.    732-321-7010    KSherwood@JFKHealth.org   
Sponsors and Collaborators
Dr Charles Porbeni
Investigators
Study Director: Michael Rosenber, M.D. JFK Medical Center
  More Information

Publications:
Responsible Party: Dr Charles Porbeni, Research Coordinator, JFK Medical Center
ClinicalTrials.gov Identifier: NCT01524666     History of Changes
Other Study ID Numbers: AgS-001
Study First Received: January 31, 2012
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Erythromelalgia
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014