Diabetic Peripheral NeuropathyNCT01368549
Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
An observational study of Diabetic Peripheral Neuropathy, run by Pamlab, L.L.C. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Metanx® (a medical food)
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®
Who may be able to join
- New Metanx® Start
- Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Metanx® (a medical food)
- Keywords
- Metanx, diabetes, neuropathy, folic acid, folate, L-methylfolate, vitamin B6, Pyridoxal 5'-phosphate, vitamin B12, methylcobalamin, DPN
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metanx® (a medical food)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Metanx® | Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily. Receives: Other: Metanx® (a medical food) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
Measured: Baseline, Week 6 and Week 12
Secondary outcomes (3)
To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS)
Measured: Baseline, Week 6 and Week 12
To determine if Metanx® affects a subject's "quality of life" as determined by a symptom impact module.
Measured: Baseline, Week 6 and Week 12
To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale
Measured: Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamlab, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InfoMedics, Inc.
- Responsible party
- Sponsor
- Investigators
- Bruce Trippe, M.D., Principal investigator, Endocrinology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368549
- Sponsor's protocol ID
- M-005
- Status last verified
- Jan 2012
- First submitted
- 17 May 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
- ClinicalTrials.gov ID
- NCT01368549
- Acronym / sponsor ID
- M-005
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Metanx, diabetes, neuropathy, folic acid, folate, L-methylfolate, vitamin B6, Pyridoxal 5'-phosphate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Pamlab, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- InfoMedics, Inc.
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metanx® | – | Other: Metanx® (a medical food)Subjects with Diabetic Peripheral Neuropathy who have been prescribed Metanx® daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Diabetic Peripheral Neuropathy Who Have Been Prescribed Metanx®
Key inclusion criteria (2 listed)
- New Metanx® Start
- Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Metanx® |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
Related trials for Diabetic Peripheral Neuropathy
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Trippe, M.D. principal investigator
Endocrinology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Pamlab, L.L.C. at 1 site 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 2 inclusion and 3 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2012.