Testing Eptinezumab against a placebo for episodic migraine
Official title: A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine
- Phase 3
- 3 groups
- Sites in Penticton, Victoria and 2 more cities
- Recruiting
Interventions
- Medication
Eptinezumab
Solution for infusion
- Medication
Placebo
Solution for infusion
Canadian Sites (4)
3 of 4 recruiting
- Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
Victoria, British Columbia
- Recruiting
Kids Clinic
Ajax, Ontario
- Recruiting
London Health Sciences Centre (LHSC)
London, Ontario
- Completed
The Medical Arts Health Research Group - Penticton
Penticton, British Columbia
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →) with history of migraine headaches of at least 6 months prior to the Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
- +During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
Exclusion
- −History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min).
- −History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, likely to affect the functions of the central nervous system.
- −Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more →. Participants with a lifetime history of psychosis and/or mania are excluded.
- −Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
- −Other inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and C receive Eptinezumab.
Registry label: A: Eptinezumab 300 mg · C: Eptinezumab 100 mg
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 6 years to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 315 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Weeks 1-12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 — measured over Baseline, Weeks 1-12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05897320 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About EptinezumabDrug
Solution for infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Solution for infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 6 years to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 6 years to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Weeks 1-12.
The study as a whole is currently expected to finish around 2027-08-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 315 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Penticton, British Columbia, Canada; Victoria, British Columbia, Canada; Ajax, Ontario, Canada; London, Ontario, Canada; Ann Arbor, Michigan, United States; Commack, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Other Sites (2)
Michigan Headache & Neurological Institute (MHNI)
Ann Arbor, Michigan, United States
True North Neurology - Commack (North Suffolk Neurology)
Commack, New York, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.