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Trial registered on ANZCTR


Registration number
ACTRN12620000598987
Ethics application status
Approved
Date submitted
1/05/2020
Date registered
22/05/2020
Date last updated
16/09/2020
Date data sharing statement initially provided
22/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed
Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older
Scientific title
A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed
Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older
Secondary ID [1] 301155 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MIG-LEV19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraines 317278 0
Condition category
Condition code
Neurological 315401 315401 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palmitoylethanolamide (PEA) can be sold as a dietary supplement for medical purposes under FSANZ (Food Standards Australia and NZ).


Palmitoylethanolamide (PEA) as Levagen+ will be taken as a 700 mg dose in capsule form (4 x 175 mg capsules) at the onset of migraine symptoms according to the International Headache Society classification.

During the enrolled period participants will be asked to complete their perceived migraine pain using a visual analogue scale (VAS). The VAS is to be completed online using the secure, personal electronic link provided at enrolment. At the requested time points the participant will be asked to score their pain by making a mark on the VAS at a point that they feel reflects the level of pain experienced at that point in time.
If the participant is unable to complete the score electronically for any reason (e.g. light sensitivity, no internet available) they will also be provided with a printable copy of the VAS that can be completed and mailed back to trial investigators. If a score is made on
paper for any time point, participants are instructed to post the original page with the score back to the trial investigators with a pre-paid and addressed envelope supplied upon request.
At the first sign of a migraine (this will be specific to the participants usual known symptoms), they will be asked to:
- Note the time and date of the migraine
- Score the pain being experienced
Take a single dose (4 capsules) of the allocated product with water once symptoms occur. For the next 4 hours or until the pain subsides (whichever occurs first):
- Score the pain severity experienced in the diary provided every 30 minutes

Rescue medication: Participants are able to consume conventional ‘rescue’ medication (e.g. ibuprofen or paracetamol) in the event the migraine does not subside within four hours from taking the allocated product.
Once they have taken rescue medication, for the next 4 hours (8 hours from the start of the migraine symptoms) they are asked to:
-Score the pain severity experienced in the diary provided every 60 minutes

The participants will be provided with enough product to complete this process on 4 occasions within 4 months of commencement.

Adherence will be monitored by recording each time a dose is taken by the participant at the start of each migraine episode.
Intervention code [1] 317462 0
Treatment: Drugs
Comparator / control treatment
The placebo will be dosed in identical capsules as Levagen+ using maltodextrin and microcrystalline cellulose mix at 700 mg (4 x 175 mg capsules) to be taken at the onset of migraine symptoms according to the International Headache Society classification.
Control group
Placebo

Outcomes
Primary outcome [1] 323650 0
Change in migraine pain/severity as assessed by VAS for pain
Timepoint [1] 323650 0
Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours (primary endpoint).
Secondary outcome [1] 382485 0
Change in migraine duration assessed by recording duration in migraine diary
Timepoint [1] 382485 0
Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours with final recording being primary endpoint.
Secondary outcome [2] 382486 0
Change in pain relief medication use as assessed by migraine diary
Timepoint [2] 382486 0
Baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hour 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours.

Eligibility
Key inclusion criteria
- Adults aged over 18
- No recent history (within 2 years) of clinically significant medical conditions including, but not limited to, malignancy (and treatment for malignancy), cardiovascular, neurological,
psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid
disease) or haematological abnormalities that are uncontrolled*.
- Participant’s full agreement and ability to consent to participation in the study
- At least 1 migraine (not headache) episode every 2 months as classified according to the
International Classification of Headache Disorders, 3rd edition (ICHD3) for migraines
published by the International Headache Society as detailed in section “Classification”
- Access to a computer or smartphone for completing online questionnaires and events.

* A medical condition will be considered uncontrolled if the participant reports ongoing treatment, a change of either medication type or dose in the past 3 months or any change in symptoms within the past 3 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of long-term medication (unless for controlled medical condition as above)
- Pregnant, trying to get pregnant or lactating women^
- Chronic past and/or current alcohol use (greater than 14 alcoholic drinks week)
- Smokers
- Allergic or hypersensitive to any of the ingredients in the active or placebo formula
- Use of preventative migraine medication
- Migraines that have reported:
o To occur on 15 or more days/month for more than 3 months, which, on at least 8
days/month, has the features of migraine headache.
o A debilitating attack lasting for more than 72 hours.
o A seizure

^ Any person suspecting they may be pregnant (e.g. missed period, nausea, fatigue) will be directed to attend their GP for a pregnancy test prior to enrolment in the trial.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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] 305598 0
Commercial sector/Industry
Name [1] 305598 0
Gencor Pacific
Address [1] 305598 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [1] 305598 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett street
Newstead, Queensland,4006
Country
Australia
Secondary sponsor category [1] 306012 0
Commercial sector/Industry
Name [1] 306012 0
Gencor Pacific
Address [1] 306012 0
21-E,Elegance
Hillgrove Village
Discovery Bay 999077
Hong Kong
Country [1] 306012 0
Hong Kong
Secondary sponsor category [2] 306015 0
Commercial sector/Industry
Name [2] 306015 0
Pharmako Biotechnologies Pty Ltd,
Address [2] 306015 0
36 Campbell Ave, Cromer NSW 2099
Country [2] 306015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305897 0
Bellberry Limited
Ethics committee address [1] 305897 0
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 305897 0
Australia
Date submitted for ethics approval [1] 305897 0
12/02/2020
Approval date [1] 305897 0
21/05/2020
Ethics approval number [1] 305897 0

Summary
Brief summary
A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed
Palmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of
migraines in otherwise healthy participants aged 18 years and older.

The aim of this study is to assess the effectiveness of Levagen+ for reducing pain severity and
duration of migraines compared to a placebo.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101978 0
Dr David Briskey
Address 101978 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 101978 0
Australia
Phone 101978 0
+61 421 784 077
Fax 101978 0
Email 101978 0
d.briskey@uq.edu.au
Contact person for public queries
Name 101979 0
Ms Amanda Rao
Address 101979 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 101979 0
Australia
Phone 101979 0
+61 414 488 559
Fax 101979 0
Email 101979 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 101980 0
Ms Amanda Rao
Address 101980 0
RDC GLOBAL Pty Ltd
3B/76 Doggett Street, Newstead, QLD, 4006
Country 101980 0
Australia
Phone 101980 0
+61 414 488 559
Fax 101980 0
Email 101980 0
amanda@rdcglobal.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 IPD will be shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results