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Trial registered on ANZCTR


Registration number
ACTRN12620001302943p
Ethics application status
Submitted, not yet approved
Date submitted
31/10/2020
Date registered
2/12/2020
Date last updated
2/12/2020
Date data sharing statement initially provided
2/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled study evaluating Palmitoylethanolamide for diabetic-related peripheral neuropathic pain, inflammation and quality of life
Scientific title
A randomised, double-blind, placebo-controlled study evaluating Palmitoylethanolamide for diabetic-related peripheral neuropathic pain, inflammation and quality of life
Secondary ID [1] 302641 0
NIl
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic-related peripheral neuropathy 319545 0
Condition category
Condition code
Metabolic and Endocrine 317495 317495 0 0
Diabetes
Neurological 317862 317862 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palmitoylethanolamide
LevagenTM+ Palmitoylethanolamide 350mg capsules
Taken twice a day (morning and evening) for 8 weeks
Adherence to the intervention will be monitored by clinical staff at interviews and by the return of the product container and counting of remaining capsules at completion of the study.
Intervention code [1] 318936 0
Treatment: Other
Comparator / control treatment
Control (placebo) Matching - 00 white capsules containing maltodextrin only
Control group
Placebo

Outcomes
Primary outcome [1] 325531 0
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.
Timepoint [1] 325531 0
Baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks (end point)
Secondary outcome [1] 388315 0
To evaluate efficacy of LevagenTM+ Palmitoylethanolamide on quality of life of those with diabetic-related peripheral neuropathy using the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN) Total score, Pain severity score and 7-item Pain Interference Index.
Timepoint [1] 388315 0
Baseline, week 2, week 4, week 6 and week 8
Secondary outcome [2] 388316 0
To evaluate effect of LevagenTM+ Palmitoylethanolamide on the frequency of use of rescue pain medication assessed/recorded at interviews.
Timepoint [2] 388316 0
Baseline, week 2, week 4, week 6 and week 8
Secondary outcome [3] 388317 0
To evaluate the effect of LevagenTM+ Palmitoylethanolamide on pathology markers: full blood count (FBC)
Timepoint [3] 388317 0
Baseline and week 8
Secondary outcome [4] 388318 0
To evaluate efficacy of LevagenTM+ Palmitoylethanolamide for diabetic-related peripheral neuropathic pain characteristics using the Neuropathic pain symptom inventory (NPSI).
Timepoint [4] 388318 0
Baseline, 4 weeks and 8 weeks
Secondary outcome [5] 389399 0
To evaluate the effect of LevagenTM+ Palmitoylethanolamide on pathology marker: glycated haemoglobin (Blood)
Timepoint [5] 389399 0
Baseline and week 8
Secondary outcome [6] 389400 0
To evaluate the effect of LevagenTM+ Palmitoylethanolamide on pathology marker: C-reactive protein (Blood)
Timepoint [6] 389400 0
Baseline and week 12
Secondary outcome [7] 389401 0
To evaluate the effect of LevagenTM+ Palmitoylethanolamide on inflammatory pathology markers: Interleukin-6 and fibrinogen.(Blood)
Timepoint [7] 389401 0
Baseline and week 8

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed.
Identical numbered containers, 001 - 066, are to be provided in order of enrolment, to participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated, based on the difference between two independent means (active and placebo groups, ratio 1:1) for the primary outcome (Pain Severity Index), using the Wilcoxon-Mann-Whitney test. For a one tailed, alpha error probability of 0.05, and size effect of 0.8, the required total sample size is 29 (29 per arm). Allowing for 10% drop-out rate, the required sample size for recruitment is total of 66 participants (in 1:1 ratio for Active group and Placebo group (i.e. 33 per treatment group). The purpose of this study is to explore the overall evaluation of efficacy of study treatments in the target populations. All data in this study will be assessed using SPSS and MS Office (Word or Excel) formats.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307077 0
Commercial sector/Industry
Name [1] 307077 0
Gencor Pacific Ltd
Address [1] 307077 0
Unit 3, 1/F, Office Building Block 2,
96 Siena Avenue, Discovery Bay North,
Lantau Island, N.T., Hong Kong

Country [1] 307077 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Gencor Pacific Ltd
Address
Unit 3, 1/F, Office Building Block 2,
96 Siena Avenue, Discovery Bay North,
Lantau Island, N.T., Hong Kong

Country
Hong Kong
Secondary sponsor category [1] 307676 0
None
Name [1] 307676 0
Address [1] 307676 0
Country [1] 307676 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307195 0
National Institute of Integrative Medicine
Ethics committee address [1] 307195 0
21 (11-23) Burwood Road, Hawthorn, Melbourne, Victoria 3122, AUSTRALIA
Ethics committee country [1] 307195 0
Australia
Date submitted for ethics approval [1] 307195 0
25/08/2020
Approval date [1] 307195 0
Ethics approval number [1] 307195 0

Summary
Brief summary
The aim of the study is to determine if Palmitoylethanolamide can reduce diabetic induced neuropathic pain and inflammation over a 8 week period. The study is a randomised clinical trial comparing Palmitoylethanolamide (active treatment) with a control (placeb0). The active treatment is a 350mg capsule taken twice daily (total 700mg/day) for 8 weeks. The outcomes being evaluated in the study are: the severity of neuropathic pain and the characteristics of the neuropathic pain, the effect of the neuropathic pain on quality of life, the use of rescue medications used during the study and the effect of the active treatment on general health pathology and inflammation markers.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 106362 0
Dr Elizabeth Steels
Address 106362 0
Evidence Sciences Pty. Ltd.
Unit 4/884 Brunswick street, New Farm 4005 QLD
Country 106362 0
Australia
Phone 106362 0
+61 431 003 929
Fax 106362 0
Email 106362 0
drbeth@evidencesciences.com.au
Contact person for public queries
Name 106363 0
Dr Elizabeth Steels
Address 106363 0
Evidence Sciences Pty. Ltd.
Unit 4/884 Brunswick street, New Farm 4005 QLD
Country 106363 0
Australia
Phone 106363 0
+61 431 003 929
Fax 106363 0
Email 106363 0
drbeth@evidencesciences.com.au
Contact person for scientific queries
Name 106364 0
Dr Elizabeth Steels
Address 106364 0
Evidence Sciences Pty. Ltd.
Unit 4/884 Brunswick street, New Farm 4005 QLD
Country 106364 0
Australia
Phone 106364 0
+61 431 003 929
Fax 106364 0
Email 106364 0
drbeth@evidencesciences.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No. Individual data will not be published. The data for each cohort will be summarised for publication as per the Participant Consent Form.
What supporting documents are/will be available?
No other documents available
Summary results
No Results