Health Trials

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

ConditionChronic Migraine in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorH. Lundbeck A/S

About this trial

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.

During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.

During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Disqualifiers

The participant has previously been randomised in this study and exposed to eptinezumab.

The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.

The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.

The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eptinezumab

    Drug

    Eptinezumab will be administered per dose and schedule specified in the arm.

  • Placebo

    Drug

    Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Treatment groups

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

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Weeks 1-12

Secondary outcomes

1

Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

Time frame
Baseline up to Weeks 1-12
2

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

Time frame
Day 1
3

Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12

Time frame
Baseline, Weeks 1-12
4

Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

Time frame
Baseline up to 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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