Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

NCT ID: NCT01524666

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Peripheral Neuropathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JFK Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Rosenberg, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Rosenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

JFK Medical Center

Locations

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JFK Medical Center

Edison, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Rosenberg, MD

Role: CONTACT

732-321-7010

Facility Contacts

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Michael D Rosenberg, M.D.

Role: primary

732-321-7010

References

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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.

Reference Type BACKGROUND
PMID: 20447305 (View on PubMed)

Rosenberg ML, Tohidi V, Sherwood K, Gayen S, Medel R, Gilad GM. Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study. Nutrients. 2020 Feb 23;12(2):576. doi: 10.3390/nu12020576.

Reference Type DERIVED
PMID: 32102167 (View on PubMed)

Other Identifiers

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AgS-001

Identifier Type: -

Identifier Source: org_study_id

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