MigrainePhase 3NCT05046522
A Study Evaluating the Effectiveness of PEA Compared to Placebo for Reducing Pain Severity and Duration of Migraines.
A Phase 3 study testing Palmitoylethanolamide sold as Levagen + in people with Migraine, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Palmitoylethanolamide sold as Levagen +
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2021to 9 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Palmitoylethanolamide sold as Levagen +, Placebo comparator - maltodextrin and microcrystalline cellulose mix
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitoylethanolamide sold as Levagen +Drug
Also called 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.
Placebo comparator - maltodextrin and microcrystalline cellulose mixDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Palmitoylethanolamide sold as Levagen + | Experimental | 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) Receives: Drug: Palmitoylethanolamide sold as Levagen + |
| A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix | Placebo comparator | 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) Receives: Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
Migraine Duration
Change in migraine duration
Measured: 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).
Pain relief medication use
Change in pain relief medication use
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Briskey, PhD, Principal investigator, RDC Global Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046522
- Sponsor's protocol ID
- MIGLEV-21
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05046522
- Acronym / sponsor ID
- MIGLEV-21
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palmitoylethanolamide sold as Levagen + | Experimental | Drug: 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 | Drug: Placebo comparator - maltodextrin and microcrystalline cellulose mixA 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palmitoylethanolamide sold as Levagen +Also: 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. | Drug | Palmitoylethanolamide sold as Levagen + |
| Placebo comparator - maltodextrin and microcrystalline cellulose mixPlacebo 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. | Drug | A comparator placebo capsule - Maltodextrin and microcrystalline cellulose mix |
Primary outcome
Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) 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 VAS (Visual Analog Scale) for pain - Minimum score = 0, Maximum score = 100. Higher scores indicate a higher level of pain/severity.
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Briskey, PhD principal investigator
RDC Global Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palmitoylethanolamide sold as Levagen + in people with Migraine, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in migraine pain/severity as assessed by VAS (Visual Analog Scale) 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.