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Diabetic Peripheral NeuropathyMEDIANNCT01990092

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

A study testing Metanx in people with Diabetic Peripheral Neuropathy and B Vitamin Deficiency, run by Pamlab, Inc. at 25 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 25 to 80 years
What is being tested?
Metanx
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
238 participants
Where
25 sitesUnited States
Study dates
Nov 2013to Mar 2018
Phase
Interventional
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 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)]
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  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • FutureSearch Trials of Neurology, L.P.

    Austin, Texas, 78731

  • Willis-Knighton Physician Network / WKB Family Medicine Associates

    Bossier City, Louisiana, 71111

  • Meridien Research

    Bradenton, Florida, 34208

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Urgent Care Specialists, LLC dba Hometown Urgent Care & Occupational Health

    Dayton, Ohio, 45424

  • Centex Studies Inc.

    Houston, Texas, 77062

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77098

  • North Chattahoochee Family Physicians, LLC

    Johns Creek, Georgia, 30097

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Strelitz Diabetes Center

    Norfolk, Virginia, 23510

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Suncoast Clinical Research

    Palm Harbor, Florida, 34684

  • CRI Lifetree

    Philadelphia, Pennsylvania, 19139

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Endeavor Clinical Trials, PA

    San Antonio, Texas, 78229

  • Center for Clinical Research, Inc.

    San Francisco, California, 94115

  • Northeast Clinical Research of San Anotnio, LLC

    Schertz, Texas, 78154

  • Trinity Clinical Research, LLC

    Tullahoma, Tennessee, 37388

  • ClinPoint Trials, LLC

    Waxahachie, Texas, 75165

  • Florida Medical Clinic

    Wesley Chapel, Florida, 33544

Other trials in United States

About this study

Official title: 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.

Being tested
Metanx, Placebo
Keywords
Metanx, B vitamins, neuropathy, nutrition
Medical subject headings
Vitamin B Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetanxOther

    Metanx is a prescription medical food.

  • PlaceboOther

Study groups in NCT01990092
Study groupRoleWhat they receive
MetanxExperimentalSubjects will take 2 Metanx tablets once daily for 48 weeks.
Receives: Other: Metanx
PlaceboPlacebo comparatorSubjects will take 2 placebo tablets once daily for 48 weeks.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in plasma methylmalonic acid (MMA) levels

    Measured: 16 weeks

Secondary outcomes (8)

  1. Change in plasma 5-methyltetrahydrofolate levels

    Measured: 16 weeks

  2. Change in plasma vitamin B6 levels

    Measured: 16 weeks

  3. Change in plasma vitamin B12 levels

    Measured: 16 weeks

  4. Change in urine microalbumin/creatinine ratio

    Measured: 48 weeks

  5. Change in epidermal nerve fiber density

    This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.

    Measured: 48 weeks

  6. Change in neuropathic disability as measured by the Michigan Neuropathy Screening Instrument part B

    This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.

    Measured: 48 weeks

  7. Change in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6questionnaire(NTSS-6)

    This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.

    Measured: 16 weeks

  8. Change in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 questionnaire (NTSS-6)

    This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionAug 2016 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990092
Sponsor's protocol ID
M-003
Acronym
MEDIAN
Status last verified
Jan 2016
First submitted
15 Nov 2013
Last updated
18 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Metanx in people with Diabetic Peripheral Neuropathy and B Vitamin Deficiency, run by Pamlab, Inc. at 25 sites 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 16 inclusion and 24 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma methylmalonic acid (MMA) levels (time frame: 16 weeks). 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 NCT01990092.

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 18 Jan 2016.

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