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NCT Number: NCT07028528

Levagen+ Efficacy Study on 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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

Location status: Recruiting

Location contact

Amanda Rao

CONTACT

[email protected]

+61 (07) 3102 4486

Amanda Rao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levagen+

Dietary Supplement

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: palmitoylethanolamide, PEA

Placebo

Other

Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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+

  3. 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.

  4. 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.

  5. 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)

  6. 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)

  7. 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).

  8. 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.

  9. 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)

  10. 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)

  11. 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).

  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).

  13. 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).

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Rao

CONTACT

[email protected]

+61(0)731024486

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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