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

H. Lundbeck A/S112 sites in 11 countries315 target enrollmentJune 8, 2023

ConditionsEpisodic Migraine

InterventionsEptinezumab Placebo

DrugsEptinezumab Placebo

Overview

Phase: Phase 3
Intervention: Eptinezumab
Conditions: Episodic Migraine
Sponsor: H. Lundbeck A/S
Enrollment: 315
Locations: 112
Primary Endpoint: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Registry

clinicaltrials.gov

Start Date

June 8, 2023

End Date

August 31, 2027

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•Other inclusion and exclusion criteria may apply.

Arms & Interventions

Eptinezumab 300 mg

Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

Intervention: Eptinezumab

Placebo

Participants will receive a single IV infusion of matching placebo to eptinezumab.

Intervention: Placebo

Eptinezumab 100 mg

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Intervention: Eptinezumab

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Weeks 1-12

Secondary Outcomes

Percentage of Participants with Migraine on the Day After Dosing (Day 1)(On Day After Dosing)
Response: ≥50% Reduction From Baseline in MMDs(Baseline, Weeks 1-4 and Weeks 1-12)
Change From Baseline in MMDs with Acute Medication Use(Baseline, Weeks 1-12)
Change From Baseline in the Number of Monthly Headache Days (MHDs)(Baseline, Weeks 1-12)
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)(Day 0 (pre-dose) and at Weeks 8, 12, and 20)
Response: ≥75% reduction from baseline in MMDs(Baseline, Weeks 1-4 and Weeks 1-12)
Change From Baseline in Monthly Hours with Headache(Baseline, Weeks 1-12)
Change From Baseline in Rate of Migraines with Severe Pain Intensity(Baseline, Weeks 1-12)
Free Eptinezumab Plasma Concentrations(Day 0 (pre-dose) and at Weeks 8, 12, and 20)
Change From Baseline in Days with Acute Medication(Baseline, Weeks 1-12)
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])(Day 0 (pre-dose) and at Weeks 8, 12, and 20)
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score(Baseline, Week 12)