Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

July 21, 2025 updated by: RDC Clinical Pty Ltd

A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy

The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN.

Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Fortitude Valley, Queensland, Australia, 4006
        • Recruiting
        • RDC Clinical
        • Principal Investigator:
          • Amanda Rao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-75 years.
  • Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).
  • Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
  • Able to provide informed consent.
  • Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
  • Agree to not participate in another clinical trial during the study period.
  • Able to attend an ACL collection centre.

Exclusion Criteria:

  • Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection [HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy]; autoimmune disease [Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome]; trauma / injury; toxins [heavy metals, chemicals]; antibiotics; or inflammatory conditions [vasculitis]).
  • Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease
  • Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia
  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
  • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
  • Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa).
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
  • Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
  • Females attempting to conceive, pregnant or lactating
  • Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula.
  • Difficulty swallowing capsules.
  • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levagen+

Take 1 capsule twice daily with water after food. Each capsule will contain:

A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA.
Dietary supplement: Levagen+
Participants will take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA
Other Names:
  • PEA
  • palmitoylethanolamide
Placebo Comparator: Placebo
Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC].
Other: Placebo
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to the end of the study period in overall severity of neuropathic pain
Time Frame: Baseline to week 12

Change from baseline to the end of the study period in overall severity of neuropathic pain, as assessed by the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN).

This is a self-reported scale, higher scores indicate greater pain and interference.
Baseline to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory (NPSI). This is a self-administered questionnaire used to evaluate neuropathic pain intensity across 5 categories, namely "superficial spontaneous pain", "deep spontaneous pain", "paroxysmal pain", "evoked pain", and "dysesthesia / paraesthesia". There are 10 pain descriptors and 2 items related to abnormal sensations. The scale ranges from 0 (no pain at all) to 10 (worst pain imaginable). The total scores of all items are combined to find the total pain intensity
Baseline to week 12
Change from baseline to the end of the study period in Safety via Adverse Event reporting
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+
Baseline to week 12
Change from baseline to the end of the study period in Safety Markers (FBC)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test.
Baseline to week 12
Change from baseline to the end of the study period in Safety Markers (E/LFT)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test.
Baseline to week 12
Change from baseline to the end of the study period in Safety (Vitals - BP)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Safety Markers vital signs (blood pressure)
Baseline to week 12
Change from baseline to the end of the study period in Safety (Vitals - heart rate)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Safety Markers vital signs (heart rate)
Baseline to week 12
Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep). This is a self-administered 12-item questionnaire that includes a Sleep Problem Index and evaluates 6 dimensions of sleep difficulty, namely: "sleep disturbance", "sleep adequacy", somnolence", "quantity of sleep/optimal sleep", "awakening short of breath or with headache", and "occurrence of snoring". The Sleep Problem Index summarises information across 9 items and is rated on a scale of 1 (all of the time) to 6 (none of the time).
Baseline to week 12
Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21). The DASS-21 is a self-reported questionnaire derived from the original 42-item DASS and is a quantitative measure of distress. It consists of 3 subscales: the depression subscale (DASS-D), anxiety subscale (DASS-A) and stress subscale (DASS-S). Each subscale contains 7 items which are rated on a 4-point severity/frequency scale. The scores for each subscale are calculated by summing the scores for the relevant items. Higher scores indicate greater distress.
Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (HbA1c)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (HbA1c)
Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (weight)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (weight).
Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (height)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (height).
Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (BMI)
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (BMI).
Baseline to week 12
Change from baseline to the end of the study period in use of rescue medication for pain
Time Frame: Baseline to week 12
Change from baseline to the end of the study period in use of rescue medication for pain. Participants will be allowed to use a rescue medication as needed, with use documented via participant diaries including date, time, dosage, reason for use. Data will be analysed based on total usage, frequency, and the proportion of participants requiring rescue medication.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RDC Clinical Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gencor Pacific Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ramasamy Venkatesh, Gencor Pacific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEULEV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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