Peripheral NeuropathyNCT01524666
Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
An observational study of Peripheral Neuropathy, run by JFK Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic patients at JFK Med CTR
Who may be able to join
- Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy
Who cannot join
- Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
JFK Medical Center
Edison, New Jersey, 07712
Michael D Rosenberg, M.D., 732-321-7010, MRosenberg@JFKHealth.org
About this study
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.
- Conditions
- Peripheral Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Questionnaire
Measured: After 2 months
Secondary outcomes (1)
QSART & ANSAR testing
Measured: After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JFK Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rosenberg, MD, JFK Medical Center
- Investigators
- Michael Rosenberg, M.D., Principal investigator, JFK Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524666
- Sponsor's protocol ID
- AgS-001
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2012
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20447305Rosenberg 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.
PubMed 32102167
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy
- ClinicalTrials.gov ID
- NCT01524666
- Acronym / sponsor ID
- AgS-001
- Conditions
- Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- JFK Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic patients at JFK Med CTR
Key inclusion criteria (1 listed)
- Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy
Key exclusion criteria (1 listed)
- Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropathic Pain Questionnaire
Time frame: After 2 months
1 secondary outcome
QSART & ANSAR testing
Time frame: After 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 20447305Keynan 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.
- Derived from this study: PubMed 32102167Rosenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rosenberg, M.D. principal investigator
JFK Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy, run by JFK Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Rosenberg, MD (732-321-7010, mrosenberg@jfkhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Questionnaire (time frame: After 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.