Levagen+ for symptoms of diabetic peripheral neuropathy
A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy
PHASE2 · RDC Clinical Pty Ltd · NCT07028528
This study will try Levagen+, a daily supplement, to see if it reduces nerve pain and other symptoms in adults with diabetic peripheral neuropathy compared with a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fortitude Valley, Queensland) |
| Trial ID | NCT07028528 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized, placebo-controlled trial tests whether daily Levagen+ reduces symptoms of diabetic peripheral neuropathy in adults. Eligible participants aged 18–75 with type 1 or type 2 diabetes on stable glucose-lowering therapy and an S-LANSS score of 12 or more will be randomized to receive Levagen+ or matching placebo for 12 weeks. Participants will have remote visits every three weeks and attend a local pathology centre for blood draws at baseline and follow-up. Symptom changes and safety measures will be monitored to determine whether Levagen+ offers a measurable benefit over placebo.
Who should consider this trial
Good fit: Adults 18–75 with type 1 or 2 diabetes who are on stable glucose-lowering medication, have an S-LANSS score of 12 or higher, can complete remote visits, and can attend a local pathology centre for blood draws are ideal candidates.
Not a fit: People whose neuropathy is caused by non-diabetic conditions, those with unstable medical conditions or recent medication changes, or those unable to comply with visits and blood draws are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Levagen+ could reduce nerve pain and other neuropathic symptoms and improve quality of life for people with diabetic peripheral neuropathy.
How similar studies have performed: Some small trials of related palmitoylethanolamide (PEA) supplements have reported symptom improvements in neuropathic pain, but results are mixed and larger randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fortitude Valley, Queensland
- RDC Clinical — Fortitude Valley, Queensland, Australia (RECRUITING)
Study contacts
- Study coordinator: Amanda Rao
- Email: research@rdcglobal.com.au
- Phone: +61(0)731024486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Peripheral Neuropathy