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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palmitoylethanolamide sold as Levagen + | Experimental | Palmitoylethanolamide in capsule form - taken as a 700mg (2 x 350mg) dosage at onset of migraine and if unresolved at 2 hours post onset a second dose of 700mg (2 x 350mg) |
|
| A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix | Placebo Comparator | A comparator capsule taken as a 700mg (2 x 350mg) dosage at onset of migraine and if unresolved at 2 hours post onset a second dose of 700mg (2 x 350mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoylethanolamide sold as Levagen + | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain Migraine Pain/Severity | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Duration | Change in 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). |
| Pain relief medication use |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| David Briskey, PhD | RDC Global Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Global Pty Ltd | Brisbane | Queensland | 4006 | Australia |
No IPD will be shared
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|
| Placebo comparator - maltodextrin and microcrystalline cellulose mix | Drug | 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. |
|
Change in 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). |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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