Overview

This trial is active, not recruiting.

Condition diabetic peripheral neuropathy
Treatment metanx® (a medical food)
Sponsor Pamlab, L.L.C.
Collaborator InfoMedics, Inc.
Start date January 2011
End date January 2012
Trial size 800 participants
Trial identifier NCT01368549, M-005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily.
metanx® (a medical food)
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.

Primary Outcomes

Measure
To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
time frame: Baseline, Week 6 and Week 12

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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).

Additional Information

Official title Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
Principal investigator Bruce Trippe, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Pamlab, Inc..