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

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ClinicalTrials.gov Identifier: NCT05046522
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Palmitoylethanolamide sold as Levagen + Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mix Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: 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)
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.
Other Name: Levagen+

Placebo Comparator: 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)
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.




Primary Outcome Measures :
  1. Reduction in migraine pain/severity as assessed by VAS for pain Migraine 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). ]
    Change in migraine pain/severity as assessed by Visual Analog Scale for pain


Secondary Outcome Measures :
  1. 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). ]
    Change in migraine duration

  2. 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). ]
    Change in pain relief medication use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046522


Contacts
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Contact: Amanda Rao, PhD +61 414 488 559 amanda@rdcglobal.com.au
Contact: David Briskey, PhD +61 421 784 077 d.briskey@uq.edu.au

Locations
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Australia, Queensland
RDC Global Pty Ltd Recruiting
Brisbane, Queensland, Australia, 4006
Contact: Amanda Rao, PhD    +61 414 488 559    amanda@rdcglobal.com.au   
Contact: David Briskey, PhD    +61 421 784 077    d.briskey@uq.edu.au   
Sponsors and Collaborators
RDC Clinical Pty Ltd
Investigators
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Principal Investigator: David Briskey, PhD RDC Global Pty Ltd
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Responsible Party: RDC Clinical Pty Ltd
ClinicalTrials.gov Identifier: NCT05046522    
Other Study ID Numbers: MIGLEV-21
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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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
Additional relevant MeSH terms:
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Migraine Disorders
Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists