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

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01368549
• Other study ID #: M-005
• Status: Unknown status
• Phase: N/A
• First received: May 17, 2011
• Last updated: January 9, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 800
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Endocrinology Associates	Montgomery	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, L.L.C.	InfoMedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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