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
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
AustraliaSite Not Available
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