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

RDC Clinical

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mix; Drug: Palmitoylethanolamide sold as Levagen +

Study type: Interventional

Funder types: Industry

Identifiers

NCT05046522

MIGLEV-21

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Palmitoylethanolamide sold as Levagen +

Experimental group

Description:

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)

Treatment:

Drug: Palmitoylethanolamide sold as Levagen +

A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mix