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Vitamin Supplement

Metanx for Diabetic Neuropathy (MEDIAN Trial)

N/A
Waitlist Available
Led By Roy Freeman, MD
Research Sponsored by Pamlab, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be male or female between 25 and 80 years of age, inclusive, at the time of consent
Have a diagnosis of diabetes mellitus Type 2 as defined by the American Diabetes Association and on stable therapy as defined per the investigator's opinion for at least 1 month before the Screening Visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

MEDIAN Trial Summary

The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks of treatment, and long-term effects will be evaluated over the duration of a 48 week treatment period.

Eligible Conditions
  • Diabetic Neuropathy
  • Vitamin B Deficiency

MEDIAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MEDIAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in plasma methylmalonic acid (MMA) levels
Secondary outcome measures
Change in epidermal nerve fiber density
Change in neuropathic disability as measured by the Michigan Neuropathy Screening Instrument part B
Change in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 questionnaire (NTSS-6)
+5 more

MEDIAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetanxExperimental Treatment1 Intervention
Subjects will take 2 Metanx tablets once daily for 48 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take 2 placebo tablets once daily for 48 weeks.

Find a Location

Who is running the clinical trial?

Pamlab, Inc.Lead Sponsor
12 Previous Clinical Trials
2,451 Total Patients Enrolled
Roy Freeman, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
6 Previous Clinical Trials
281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~21 spots leftby Mar 2025