A Study Evaluating the Effectiveness of PEA Compared to Placebo for Reducing Pain Severity and Duration of Migraines.

Last updated: October 22, 2023
Sponsor: RDC Clinical Pty Ltd
Overall Status: Completed

Phase

3

Condition

Pain

Migraine (Adult)

Chronic Pain

Treatment

Palmitoylethanolamide sold as Levagen +

Placebo comparator - maltodextrin and microcrystalline cellulose mix

Clinical Study ID

NCT05046522
MIGLEV-21
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Adults aged over 18
  • No recent history (within 2 years) of clinically significant medical conditionsincluding, but not limited to, malignancy (and treatment for malignancy),cardiovascular, neurological, psychiatric, renal, immunological, endocrine (includinguncontrolled diabetes or thyroid disease) or haematological abnormalities that areuncontrolled*.
  • 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 tothe International Classification of Headache Disorders, 3rd edition (ICHD3) formigraines published by the International Headache Society as detailed in section "Classification"
  • Access to a computer or smartphone for completing online questionnaires and events.

Exclusion

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 8days/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 participantreports ongoing treatment, a change of either medication type or dose in thepast 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 priorto enrolment in the trial.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Palmitoylethanolamide sold as Levagen +
Phase: 3
Study Start date:
September 01, 2021
Estimated Completion Date:
March 09, 2023

Connect with a study center

  • RDC Global Pty Ltd

    Brisbane, Queensland 4006
    Australia

    Site Not Available

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