Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
This study is currently recruiting participants.
Verified February 2012 by JFK Medical Center
Sponsor:
Dr Charles Porbeni
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
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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:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
small fiber neuropathy
U.S. FDA Resources
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
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 |
Neuromuscular Diseases Nervous System Diseases Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013