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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Palmitoylethanolamide sold as Levagen +
Placebo comparator - maltodextrin and microcrystalline cellulose mix
Sponsored by
RDC Clinical Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • RDC Global Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Palmitoylethanolamide sold as Levagen +

A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix

Arm 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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Migraine Duration
Change in migraine duration
Pain relief medication use
Change in pain relief medication use

Full Information

First Posted
September 8, 2021
Last Updated
October 22, 2023
Sponsor
RDC Clinical Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05046522
Brief Title
A Study Evaluating the Effectiveness of PEA Compared to Placebo for Reducing Pain Severity and Duration of Migraines.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDC Clinical Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palmitoylethanolamide sold as Levagen +
Arm Type
Experimental
Arm 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)
Arm Title
A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Palmitoylethanolamide sold as Levagen +
Other Intervention Name(s)
Levagen+
Intervention Description
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
Intervention Name(s)
Placebo comparator - maltodextrin and microcrystalline cellulose mix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) for pain Migraine Pain/Severity
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Migraine Duration
Description
Change in migraine duration
Time Frame
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).
Title
Pain relief medication use
Description
Change in pain relief medication use
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Briskey, PhD
Organizational Affiliation
RDC Global Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
RDC Global Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared

Learn more about this trial

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

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