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

Study Overview
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Brief Summary
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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.

Detailed Description
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The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Official Title
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Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Conditions
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Chronic Migraine in Children

Intervention / Treatment
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* Drug: Eptinezumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab 300 mg<br>Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted). | Drug: Eptinezumab<br>* Eptinezumab will be administered per dose and schedule specified in the arm.<br>* Other names: Vyepti;|
| Experimental: Eptinezumab 100 mg<br>Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). | Drug: Eptinezumab<br>* Eptinezumab will be administered per dose and schedule specified in the arm.<br>* Other names: Vyepti;|
| Placebo Comparator: Placebo<br>Participants will receive a single IV infusion of placebo matching to eptinezumab. | Drug: Placebo<br>* Placebo matching to eptinezumab will be administered per schedule specified in the arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 |  | Baseline up to Weeks 1-12 | 
| Percentage of Participants With Migraine on the Day After Dosing (Day 1) |  | Day 1 | 
| Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 
| Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 |  | Baseline up to Weeks 1-12 | 
| Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 |  | Baseline up to Weeks 1-4 | 
| Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 |  | Baseline up to Weeks 1-4 | 
| Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 
| Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 
| Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 
| Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 |  | Baseline, Weeks 1-12 | 
| Free Eptinezumab Plasma Concentration |  | Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20) | 
| Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) |  | From randomization (Week 0) up to Week 20 | 
| Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) |  | From randomization (Week 0) up to Week 20 |