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

Diabetic Peripheral Neuropathy Clinical Trial

— MEDIAN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01990092
• Other study ID #: M-003
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: January 15, 2016
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: January 2016
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: March 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Avitaminosis
• B Vitamin Deficiency
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Metanx
Metanx is a prescription medical food.
• Placebo

Locations

Country	Name	City	State
United States	FutureSearch Trials of Neurology, L.P.	Austin	Texas
United States	Willis-Knighton Physician Network / WKB Family Medicine Associates	Bossier City	Louisiana
United States	Meridien Research	Bradenton	Florida
United States	PAB Clinical Research	Brandon	Florida
United States	Urgent Care Specialists, LLC dba Hometown Urgent Care & Occupational Health	Dayton	Ohio
United States	Centex Studies Inc.	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	North Chattahoochee Family Physicians, LLC	Johns Creek	Georgia
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	Collaborative Neuroscience Network, LLC	Long Beach	California
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Strelitz Diabetes Center	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Suncoast Clinical Research	Palm Harbor	Florida
United States	CRI Lifetree	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Center for Clinical Research, Inc.	San Francisco	California
United States	Northeast Clinical Research of San Anotnio, LLC	Schertz	Texas
United States	Trinity Clinical Research, LLC	Tullahoma	Tennessee
United States	ClinPoint Trials, LLC	Waxahachie	Texas
United States	Florida Medical Clinic	Wesley Chapel	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pamlab, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma methylmalonic acid (MMA) levels		16 weeks	No
Secondary	Change in plasma 5-methyltetrahydrofolate levels		16 weeks	No
Secondary	Change in plasma vitamin B6 levels		16 weeks	No
Secondary	Change in plasma vitamin B12 levels		16 weeks	No
Secondary	Change in urine microalbumin/creatinine ratio		48 weeks	Yes
Secondary	Change in epidermal nerve fiber density	This neuropathy-specific measure will be evaluated to monitor for signs of disease progression.	48 weeks	Yes
Secondary	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.	48 weeks	Yes
Secondary	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.	16 weeks	Yes
Secondary	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.	48 weeks	Yes