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

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Palmitoylethanolamide sold as Levagen +; Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mix

• Registration Number: NCT05046522
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-16
• Status Verified: 2022-12
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palmitoylethanolamide sold as Levagen +	Palmitoylethanolamide sold as Levagen +	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 - maltodextrin and microcrystalline cellulose mix	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)

Primary Outcome Measures

Name	Time	Method
Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain Migraine 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).	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.

Secondary Outcome Measures

Name	Time	Method
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).	Change in migraine duration
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).	Change in pain relief medication use

Trial Locations

Locations (1)

RDC Global Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia