Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 2:25 AM
Study NCT ID:
NCT01524666
Status:
UNKNOWN
Last Update Posted:
2018-02-28
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Skin Biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropathic Pain Questionnaire', 'timeFrame': 'After 2 months'}], 'secondaryOutcomes': [{'measure': 'QSART & ANSAR testing', 'timeFrame': 'After 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '20447305', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32102167', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinic patients at JFK Med CTR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy'}, 'identificationModule': {'nctId': 'NCT01524666', 'briefTitle': 'Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'JFK Medical Center'}, 'officialTitle': 'Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy', 'orgStudyIdInfo': {'id': 'AgS-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '07712', 'city': 'Edison', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael D Rosenberg, M.D.', 'role': 'CONTACT', 'email': 'MRosenberg@JFKHealth.org', 'phone': '732-321-7010'}], 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}], 'centralContacts': [{'name': 'Michael Rosenberg, MD', 'role': 'CONTACT', 'email': 'mrosenberg@jfkhealth.org', 'phone': '732-321-7010'}], 'overallOfficials': [{'name': 'Michael Rosenberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JFK Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JFK Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michael Rosenberg, MD', 'investigatorAffiliation': 'JFK Medical Center'}}}}