Diabetic Peripheral NeuropathyPhase 2NCT07028528
Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
A Phase 2 study testing Levagen+ in people with Diabetic Peripheral Neuropathy, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Levagen+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2025to May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
RDC Clinical
Fortitude Valley, Queensland, 4006
Amanda Rao, +61 (07) 3102 4486, research@rdcglobal.com.au
Amanda Rao
About this study
Official title: 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Levagen+, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levagen+Dietary supplement
Also called palmitoylethanolamide, PEA
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
PlaceboOther
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Levagen+ |
| Placebo | Placebo comparator | Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 12
Secondary outcomes (14)
Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory
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
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety via Adverse Event reporting
Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety Markers (FBC)
Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety Markers (E/LFT)
Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety (Vitals - BP)
Change from baseline to the end of the study period in Safety Markers vital signs (blood pressure)
Measured: Baseline to week 12
Change from baseline to the end of the study period in Safety (Vitals - heart rate)
Change from baseline to the end of the study period in Safety Markers vital signs (heart rate)
Measured: Baseline to week 12
Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep)
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).
Measured: Baseline to week 12
Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21)
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.
Measured: Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (HbA1c)
Change from baseline to the end of the study period in Glycaemic control (HbA1c)
Measured: Baseline to week 12
Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
Measured: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (weight)
Change from baseline to the end of the study period in Anthropometry (weight).
Measured: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (height)
Change from baseline to the end of the study period in Anthropometry (height).
Measured: Baseline to week 12
Change from baseline to the end of the study period in Anthropometry (BMI)
Change from baseline to the end of the study period in Anthropometry (BMI).
Measured: Baseline to week 12
Change from baseline to the end of the study period in use of rescue medication for pain
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.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, placebo-controlled, parallel dose response study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Ramasamy Venkatesh, Study director, Gencor Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028528
- Sponsor's protocol ID
- NEULEV
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07028528
- Acronym / sponsor ID
- NEULEV
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, single-blind, placebo-controlled, parallel dose response study
| Arm | Type | Receives |
|---|---|---|
| Levagen+ | Experimental | Dietary Supplement: 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. |
| Placebo | Placebo comparator | Other: PlaceboTake 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC]. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Levagen+Also: palmitoylethanolamide, PEAParticipants 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 | Dietary supplement | Levagen+ |
| PlaceboParticipants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose [MCC] | Other | Placebo |
Primary outcome
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.
14 secondary outcomes
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 Safety via Adverse Event reporting
Time frame: 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 (E/LFT)
Time frame: 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 (Vitals - heart rate)
Time frame: 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 Depression Anxiety and Stress Scale (DASS-21)
Time frame: 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 (fasting blood glucose)
Time frame: 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 (height)
Time frame: 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 use of rescue medication for pain
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ramasamy Venkatesh study director
Gencor Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levagen+ in people with Diabetic Peripheral Neuropathy, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rao (+61(0)731024486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of the study period in overall severity of neuropathic pain (time frame: Baseline to 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 23 Jul 2025.