Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

Study Overview
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Brief Summary
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This study will be an observational study in which patients who have been prescribed Metanx® are invited to participate in surveys regarding their experiences with Metanx®. The purpose of this study is to increase the understanding of the role of Metanx® in managing diabetic neuropathy, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for diabetic neuropathy.

Detailed Description
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Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy.

Official Title
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Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: Metanx® (a medical food)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New Metanx® Start Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction. Exclusion Criteria: Patients who do not meet ADA criteria for DPN diagnosis. If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s). For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metanx®<br>Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily. | Other: Metanx® (a medical food)<br>* Metanx® is an orally-administered medical food, and each tablet contains 3mg of L-methylfolate, 35mg of Pyridoxal-5'-phosphate, and 2 mg of Methylcobalamin- which are the biologically active and immediately bioavailable forms of folate, vitamin B6, and vitamin B12, respectively. Dosage will be 1 tablet BID.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6) |  | Baseline, Week 6 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS) |  | Baseline, Week 6 and Week 12 | 
| To determine if Metanx® affects a subject's quality of life as determined by a symptom impact module. |  | Baseline, Week 6 and Week 12 | 
| To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale |  | Baseline, Week 6 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metanx, diabetes, neuropathy, folic acid, folate, L-methylfolate, vitamin B6, Pyridoxal 5'-phosphate, vitamin B12, methylcobalamin, DPN