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Vitamin Supplement

Metanx for Peripheral Neuropathy (SLHN2011-18 Trial)

N/A
Waitlist Available
Led By Edwin S. Hart III, DPM
Research Sponsored by St. Luke's Hospital and Health Network, Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 Diabetics
Symptoms of peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

SLHN2011-18 Trial Summary

This trial is testing whether Metanx can improve nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two groups, with one taking Metanx and the other taking a placebo pill. Enrollment is open to pre-diabetic patients and those with type 2 diabetes who have had the condition for less than 5 years.

Who is the study for?
This trial is for adults with type 2 diabetes or pre-diabetes who have symptoms of peripheral neuropathy. It's not open to individuals under 18, pregnant women, or those with HIV.Check my eligibility
What is being tested?
The study tests Metanx®, a treatment aimed at reversing nerve damage in diabetic patients with neuropathy, against a placebo. Participants will be randomly assigned to one of two groups and monitored over twelve months through biopsies and questionnaires.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include reactions typical of vitamin supplements since Metanx® contains active forms of folate, B6, and B12 vitamins.

SLHN2011-18 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes.
Select...
I experience numbness, tingling, or pain in my hands or feet.

SLHN2011-18 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Increased intraepidermal nerve fiber density
Secondary outcome measures
Subjective improvement

SLHN2011-18 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MetanxActive Control1 Intervention
Metanx group will receive one pill twice daily for twelve months.
Group II: PlaceboPlacebo Group1 Intervention
The control group will receive placebo pill twice daily for twelve months.

Find a Location

Who is running the clinical trial?

Goldfarb FoundationUNKNOWN
Pamlab, L.L.C.Industry Sponsor
6 Previous Clinical Trials
1,575 Total Patients Enrolled
St. Luke's Hospital and Health Network, PennsylvaniaLead Sponsor
14 Previous Clinical Trials
2,004,050 Total Patients Enrolled

Media Library

Metanx (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT01503892 — N/A
Peripheral Neuropathy Research Study Groups: Placebo, Metanx
Peripheral Neuropathy Clinical Trial 2023: Metanx Highlights & Side Effects. Trial Name: NCT01503892 — N/A
Metanx (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01503892 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for the clinical trial?

"The clinicaltrials.gov page indicates that this medical study is no longer actively seeking participants, as the original posting on December 1st 2011 was last updated July 16th 2012. However, there are currently 336 other trials recruiting patients at this time."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
St. Luke's Hospital and Health Network
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Edwin S. Hart III 2011. "Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01503892.
All > Peripheral Neuropathy
~7 spots leftby Apr 2025
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