Health Trials

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

ConditionEpisodic Migraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorH. Lundbeck A/S

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.

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.

Disqualifiers

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 investigator'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 Visit. 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eptinezumab

    Drug

    Solution for infusion

  • Placebo

    Drug

    Solution for infusion

Treatment groups

315 Participants
are divided into 3 treatment groups
Group A: Eptinezumab 300 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Eptinezumab 100 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

Time frame
Baseline, Weeks 1-12

Secondary outcomes

1

Response: ≥50% Reduction From Baseline in MMDs

Time frame
Baseline, Weeks 1-4 and Weeks 1-12
2

Percentage of Participants with Migraine on the Day After Dosing (Day 1)

Time frame
On Day After Dosing
3

Change From Baseline in MMDs with Acute Medication Use

Time frame
Baseline, Weeks 1-12
4

Response: ≥75% reduction from baseline in MMDs

Time frame
Baseline, Weeks 1-4 and Weeks 1-12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lundbeck A/S

Lead sponsor

Source ClinicalTrials.gov
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