Migraine
Conditions
Brief summary
This is 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.
Interventions
DRUGPalmitoylethanolamide sold as Levagen +
Investigational product to be taken as a 700mg (2 x 350mg) dosage at onset of migraine. If unresolved at 2 hours post onset of migraine, a second dose of 700mg (2 x 350mg) is to be taken.
DRUGPlacebo comparator - maltodextrin and microcrystalline cellulose mix
Placebo product to be taken as a 700mg (2 x 350mg) dosage at onset of migraine. If unresolved at 2 hours post onset of migraine, a second dose of 700mg (2 x 350mg) is to be taken.
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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: * 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. * A debilitating attack lasting for more than 72 hours. * A seizure * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain Migraine Pain/Severity | Baseline (onset of migraine), 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). | Change in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain - Minimum score = 0, Maximum score = 100. Higher scores indicate a higher level of pain/severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Duration | Baseline (onset of migraine), 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). | Change in migraine duration |
| Pain relief medication use | Baseline (onset of migraine), 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). | Change in pain relief medication use |
Countries
Australia
Outcome results
None listed