A double-blind randomised controlled study to evaluate the effectiveness of orally-dosedPalmitoylethanolamide (PEA) compared to placebo for reducing pain severity and duration of migraines in otherwise healthy participants aged 18 years and older
- Conditions
- Neurological - Other neurological disordersMigraines
- Registration Number
- ACTRN12620000598987
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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.
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in migraine pain/severity as assessed by VAS for pain[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). <br>]
- Secondary Outcome Measures
Name Time Method Change in migraine duration assessed by recording duration in migraine diary[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. ];Change in pain relief medication use as assessed by migraine diary[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. ]