Clinical trial NCT05046522: A Study Evaluating the Effectiveness of PEA Compared to Placebo for Reducing Pain Severity and Duration of Migraines.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain Migraine Pain/Severity
timeFrame: 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).
Secondary outcomes:
measure: Migraine Duration
timeFrame: 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: Pain relief medication use
timeFrame: 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).
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Global Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Global Pty Ltd
name: David Briskey, PhD
role: PRINCIPAL_INVESTIGATOR
References: