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

NCT ID: NCT05046522

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-03-09

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Palmitoylethanolamide sold as Levagen +

Intervention Type: DRUG

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.

A comparator placebo capsule - 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)

Group Type: PLACEBO_COMPARATOR

Placebo comparator - maltodextrin and microcrystalline cellulose mix

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Levagen+

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RDC Clinical Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Briskey, PhD

Role: PRINCIPAL_INVESTIGATOR

RDC Global Pty Ltd

Locations

RDC Global Pty Ltd

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

MIGLEV-21

Identifier Type: -

Identifier Source: org_study_id