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Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

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ClinicalTrials.gov Identifier: NCT01524666
Recruitment Status : Recruiting
First Posted : February 2, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Rosenberg, MD, JFK Medical Center

Tracking Information
First Submitted Date January 31, 2012
First Posted Date February 2, 2012
Last Update Posted Date February 28, 2018
Study Start Date February 2012
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2012)
Neuropathic Pain Questionnaire [ Time Frame: After 2 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01524666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 1, 2012)
QSART & ANSAR testing [ Time Frame: After 2 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
Official Title Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Skin Biopsy
Sampling Method Non-Probability Sample
Study Population Clinic patients at JFK Med CTR
Condition Peripheral Neuropathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Keynan O, Mirovsky Y, Dekel S, Gilad VH, Gilad GM. Safety and Efficacy of Dietary Agmatine Sulfate in Lumbar Disc-associated Radiculopathy. An Open-label, Dose-escalating Study Followed by a Randomized, Double-blind, Placebo-controlled Trial. Pain Med. 2010 Mar;11(3):356-68. doi: 10.1111/j.1526-4637.2010.00808.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 1, 2012)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michael Rosenberg, MD 732-321-7010 mrosenberg@jfkhealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01524666
Other Study ID Numbers AgS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Rosenberg, MD, JFK Medical Center
Study Sponsor JFK Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Michael Rosenberg, M.D. JFK Medical Center
PRS Account JFK Medical Center
Verification Date February 2018