The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
315
Solution for infusion
Solution for infusion
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Response: ≥50% Reduction From Baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Time frame: On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use
Time frame: Baseline, Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time frame: Baseline, Weeks 1-12
Change From Baseline in Monthly Hours with Headache
Time frame: Baseline, Weeks 1-12
Change From Baseline in Days with Acute Medication
Time frame: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Time frame: Baseline, Weeks 1-12
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time frame: Baseline, Week 12
Free Eptinezumab Plasma Concentrations
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Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
RECRUITINGChild Neurology of NW Florida
Gulf Breeze, Florida, United States
RECRUITINGA G A Clinical Trials
Hialeah, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGUniversity of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, United States
RECRUITINGUniversity of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGMichigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
COMPLETEDNorth Suffolk Neurology-Commack
Commack, New York, United States
RECRUITINGOnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
COMPLETEDChildrens Hospital Medical Center of Akron
Akron, Ohio, United States
RECRUITING...and 53 more locations
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20