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
RDC Global Pty Ltd
80 participants
Jun 10, 2020
Interventional
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria12
- 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.
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Interventions
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.
Locations(1)
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ACTRN12620000598987