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

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046522
• Other study ID #: MIGLEV-21
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: March 9, 2023

Study information

• Verified date: December 2022
• Source: RDC Clinical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Pain

Intervention

Drug:
• Palmitoylethanolamide 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.
• Placebo 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.

Locations

Country	Name	City	State
Australia	RDC Global Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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).
Secondary	Pain relief medication use	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).