Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

NCT07028528 | Recruiting Phase 2

• 1 other identifier: NEULEV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of the study period in overall severity of neuropathic pain

  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 Outcomes (14)

• Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory

  Baseline to week 12

• Change from baseline to the end of the study period in Safety via Adverse Event reporting

  Baseline to week 12

• Change from baseline to the end of the study period in Safety Markers (FBC)

  Baseline to week 12

• Change from baseline to the end of the study period in Safety Markers (E/LFT)

  Baseline to week 12

• Change from baseline to the end of the study period in Safety (Vitals - BP)

  Baseline to week 12

Study Arms (2)

Levagen+

EXPERIMENTAL

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+

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Also known as: palmitoylethanolamide, PEA

Levagen+

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited: collaborator

Study Sites (1)

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Interventions

palmidrol

Study Officials

• Ramasamy Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Central Study Contacts

Amanda Rao

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, placebo-controlled, parallel dose response study

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-06

Locations

AU (1)