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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07028528
Registration number
NCT07028528
Ethics application status
Date submitted
15/05/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Titles & IDs
Public title
Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
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Scientific title
A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy
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Secondary ID [1]
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NEULEV
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Peripheral Neuropathy
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Condition category
Condition code
Neurological
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Other neurological disorders
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Levagen+
Other interventions - Placebo
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.
Placebo comparator: Placebo - Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\].
Treatment: Other: 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 interventions: Placebo
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline to the end of the study period in overall severity of neuropathic pain
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to week 12
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Secondary outcome [1]
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Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory
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Assessment method [1]
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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
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Timepoint [1]
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Baseline to week 12
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Secondary outcome [2]
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Change from baseline to the end of the study period in Safety via Adverse Event reporting
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Assessment method [2]
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Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+
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Timepoint [2]
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Baseline to week 12
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Secondary outcome [3]
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Change from baseline to the end of the study period in Safety Markers (FBC)
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Assessment method [3]
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Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test.
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Timepoint [3]
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Baseline to week 12
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Secondary outcome [4]
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Change from baseline to the end of the study period in Safety Markers (E/LFT)
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Assessment method [4]
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Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test.
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Timepoint [4]
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Baseline to week 12
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Secondary outcome [5]
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Change from baseline to the end of the study period in Safety (Vitals - BP)
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Assessment method [5]
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Change from baseline to the end of the study period in Safety Markers vital signs (blood pressure)
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Timepoint [5]
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Baseline to week 12
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Secondary outcome [6]
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Change from baseline to the end of the study period in Safety (Vitals - heart rate)
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Assessment method [6]
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Change from baseline to the end of the study period in Safety Markers vital signs (heart rate)
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Timepoint [6]
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Baseline to week 12
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Secondary outcome [7]
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Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep)
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline to week 12
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Secondary outcome [8]
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Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to week 12
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Secondary outcome [9]
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Change from baseline to the end of the study period in Glycaemic control (HbA1c)
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Assessment method [9]
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Change from baseline to the end of the study period in Glycaemic control (HbA1c)
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Timepoint [9]
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Baseline to week 12
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Secondary outcome [10]
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Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
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Assessment method [10]
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Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose)
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Timepoint [10]
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Baseline to week 12
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Secondary outcome [11]
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Change from baseline to the end of the study period in Anthropometry (weight)
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Assessment method [11]
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Change from baseline to the end of the study period in Anthropometry (weight).
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Timepoint [11]
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Baseline to week 12
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Secondary outcome [12]
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Change from baseline to the end of the study period in Anthropometry (height)
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Assessment method [12]
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Change from baseline to the end of the study period in Anthropometry (height).
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Timepoint [12]
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Baseline to week 12
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Secondary outcome [13]
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Change from baseline to the end of the study period in Anthropometry (BMI)
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Assessment method [13]
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Change from baseline to the end of the study period in Anthropometry (BMI).
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Timepoint [13]
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Baseline to week 12
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Secondary outcome [14]
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Change from baseline to the end of the study period in use of rescue medication for pain
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline to week 12
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Clinical - Fortitude Valley
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Recruitment postcode(s) [1]
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4006 - Fortitude Valley
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Gencor Pacific Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07028528
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ramasamy Venkatesh
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Address
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Gencor Pacific
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amanda Rao
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Address
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Country
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Phone
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+61(0)731024486
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07028528
Download to PDF