A randomised, double-blind, placebo-controlled study evaluating Palmitoylethanolamide for diabetic-related peripheral neuropathic pain, inflammation and quality of life

Not Applicable

Completed

• Conditions: diabetic-related peripheral neuropathy; Metabolic and Endocrine - Diabetes; Neurological - Other neurological disorders

• Registration Number: ACTRN12620001302943
• Lead Sponsor: Gencor Pacific Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-02
• Study Completion: 2021-08-14
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Male and female participants aged 18 years and above
Diagnosed with type 1 diabetes or type 2 diabetes
Currently prescribed medications for diabetes, including metformin and/or insulin
Have been medically diagnosed with peripheral neuropathy
Experiencing neuropathic pain for > 3 months
Score >4 on Neuropathic Pain Diagnostic Questionnaire (DN4) OR Score >12 on Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (s-LANSS).
Participants who can provide informed consent.

Exclusion Criteria

Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put participant at risk of adverse events.
Potential for peripheral neuropathy due to the following causes will be excluded: hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, prolonged phenytoin or immunosuppressive drug use.
Pregnant, planning to become pregnant or breastfeeding women.
Those with alcohol or substance abuse health issues.
Allergy or sensitivity to any of the ingredients in the investigational products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of LevagenTM+ Palmitoylethanolamide for diabetic-related neuropathic pain using the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN) 4-item Pain Severity Index.[Baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks (end point) ]