The Nutritional Benefits of Metanx in Patients With Diabetic Peripheral Neuropathy (MEDIAN) (MEDIAN)

January 15, 2016 updated by: Pamlab, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Nutritional Benefits of Metanx® in Subjects With Diabetic Peripheral Neuropathy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • California
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network, LLC
      • San Francisco, California, United States, 94115
        • Center for Clinical Research, Inc.
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Palm Harbor, Florida, United States, 34684
        • Suncoast Clinical Research
      • Wesley Chapel, Florida, United States, 33544
        • Florida Medical Clinic
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • North Chattahoochee Family Physicians, LLC
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Willis-Knighton Physician Network / WKB Family Medicine Associates
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • Ohio
      • Dayton, Ohio, United States, 45424
        • Urgent Care Specialists, LLC dba Hometown Urgent Care & Occupational Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Lifetree
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Trinity Clinical Research, LLC
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology, L.P.
      • Houston, Texas, United States, 77098
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77062
        • Centex Studies Inc.
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, PA
      • Schertz, Texas, United States, 78154
        • Northeast Clinical Research of San Anotnio, LLC
      • Waxahachie, Texas, United States, 75165
        • ClinPoint Trials, LLC
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Strelitz Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Have a diagnosis of DPN established at least 6 months but not greater than 7 years prior to Screening

  • If receiving DPN-related medication, doses must be stable for at least 6 weeks and should be taking only one of the following medications compliant with Exclusion Criterion 7:

    • Alpha-2-delta ligand [e.g., pregabalin (Lyrica) or gabapentin (Neurontin)
    • Anticonvulsant [e.g., carbamazepine, topiramate (Topamax), valproic acid (Depakote) or lamotrigine (Lamictal)]
    • Serotonin-norepinephrine Reuptake Inhibitor (SNRI) [e.g., duloxetine (Cymbalta) or venlafaxine (Effexor)]
    • Tricyclic antidepressant (TCA) [e.g., amitriptyline, nortriptyline, imipramine, and desipramine (Norpramin, Pertofrane)]
  • Have a score between 3 and 6, inclusive, on the Michigan Neuropathy Screening Instrument (MNSI) Part b
  • Have a minimum score of 6 on the NTSS-6 at Screening
  • Have negative urinalysis for drugs of abuse, such as amphetamines, barbiturates, cannabinoids, cocaine, or opiates
  • Have a negative urine pregnancy test at Screening if female and of childbearing potential
  • If female, must be either of nonchildbearing potential (surgically sterile or 2 years postmenopausal) or agree to use two methods of effective contraception such as hormonal contraception, intrauterine device or other mechanical contraception device, or condom plus spermicide during the subject's participation
  • If male, must be surgically sterile or agree to use two methods of effective contraception such as condom plus spermicide during the subject's participation
  • Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
  • Have provided written authorization for use and disclosure of protected health information

Exclusion Criteria:

  • Be pregnant or lactating
  • Have a history of amputation, skin ulceration, and/or active Charcot of either foot
  • Have a history of previous surgery involving the spine or lower extremity, with residual symptoms of pain or difficulty with movement
  • Have Crohn's disease or a history of any type of bariatric surgery or any surgical resection of all or part of the stomach, duodenum, jejunum, and/or ileum. (Previous surgical resections of the colon that spared the stomach, duodenum, jejunum and ileum are allowed.)
  • Have a history of surgery or hospitalization within 2 months prior to Screening or planned hospitalization at any time during the study
  • Be taking systemic corticosteroids within 2 months prior to Screening, opiates or tramadol hydrochloride within 6 weeks prior to Screening, and/or immunosuppressives, or receiving radiotherapy within 6 months prior to Screening
  • Be taking more than one anticonvulsant, serotonin-norepinephrine reuptake inhibitor (SNRI), or tricyclic antidepressant (TCA)
  • Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot, history of claudication, or history of lower extremity vascular bypass surgery or angioplasty
  • Have circulating glycated hemoglobin (HbA1c) exceeding 11% at Screening
  • Have an estimated glomerular filtration rate (eGFR) less than or equal to 40 ml/min using the Modification of Diet in Renal Disease (MDRD) formula at Screening or have end-stage renal disorder requiring hemodialysis
  • Have uncontrolled hypertension defined as sustained systolic blood pressure (SBP) greater than 200 mmHg or diastolic blood pressure (DBP) greater than 110 mmHg at screening
  • Have lung disease (uncontrolled asthma or shortness of breath) within 2 months prior to Screening
  • Use of any of the following supplements within 6 weeks before Screening: evening primrose oil, vitamin B12 injection, greater than 10 mg of vitamin B6, or greater than 800 µg of folate
  • Have previously failed two or more prior therapies for painful DPN
  • Currently abusing alcohol or drugs or have a history of such abuse within the past 3 years. (Alcohol abuse is defined as more than 2 drink units per day for women and more than 3 drink units per day for men. One drink unit is defined as 1.5 oz [45 mL] of distilled spirits, 5 oz [150 mL] of wine, or 12 oz [360 mL] of beer.)
  • Have any nondiabetic cause of peripheral neuropathy
  • Have a history of documented lumbar nerve entrapment or symptoms suggestive of a lumbar nerve entrapment
  • Have a history of systemic lupus erythematosis, rheumatoid arthritis, Sjögren's syndrome, or mixed connective tissue disease
  • If receiving thyroid replacement therapy, should be on a stable dose for at least 6 weeks prior to Screening
  • Have a history of a positive HIV test or active Hepatitis B or C infection.
  • Have a history or presence of malignancy within 10 years prior to Screening except for basal or squamous cell carcinoma of the skin. Records to be submitted to Pamlab for review and approval to randomize.
  • Have prior use of or intolerance to Metanx® or any of its active ingredients
  • Have been dosed or used a medical device in another investigational trial within 60 days prior to Screening.
  • Have any clinically significant existing medical, psychiatric, or nonmedical condition that in the opinion of the investigator places the subject at undue risk, prevents compliance with the study protocol, or potentially jeopardizes the quality of the data to be generated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metanx
Subjects will take 2 Metanx tablets once daily for 48 weeks.
Other: Metanx
Metanx is a prescription medical food.
Placebo Comparator: Placebo
Subjects will take 2 placebo tablets once daily for 48 weeks.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in plasma methylmalonic acid (MMA) levels
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in plasma 5-methyltetrahydrofolate levels
Time Frame: 16 weeks
16 weeks
Change in plasma vitamin B6 levels
Time Frame: 16 weeks
16 weeks
Change in plasma vitamin B12 levels
Time Frame: 16 weeks
16 weeks
Change in urine microalbumin/creatinine ratio
Time Frame: 48 weeks
48 weeks
Change in epidermal nerve fiber density
Time Frame: 48 weeks
This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.
48 weeks
Change in neuropathic disability as measured by the Michigan Neuropathy Screening Instrument part B
Time Frame: 48 weeks
This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.
48 weeks
Change in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6questionnaire(NTSS-6)
Time Frame: 16 weeks
This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.
16 weeks
Change in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 questionnaire (NTSS-6)
Time Frame: 48 weeks
This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamlab, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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