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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
Must not have
HIV (+)
Under age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Increased intraepidermal nerve fiber density
Secondary study objectives
Subjective improvement

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
Nerve Damage Research Study Groups: Placebo, Metanx
Nerve Damage 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
~7 spots leftby Nov 2025
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