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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
285
Eptinezumab will be administered per dose and schedule specified in the arm.
Placebo matching to eptinezumab will be administered per schedule specified in the arm.
Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Time frame: Baseline up to Weeks 1-12
Percentage of Participants With Migraine on the Day After Dosing (Day 1)
Time frame: Day 1
Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Time frame: Baseline up to Weeks 1-12
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Time frame: Baseline up to Weeks 1-4
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Time frame: Baseline up to Weeks 1-4
Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
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Yale-New Haven Children's Hospital - PIN
New Haven, Connecticut, United States
RECRUITINGKi Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
RECRUITINGChildren's National Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGNW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
RECRUITINGAGA Clinical Trials
Hialeah, Florida, United States
RECRUITINGAxcess Medical Research
Loxahatchee Groves, Florida, United States
COMPLETEDUniversity of South Florida
Tampa, Florida, United States
RECRUITINGClinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
RECRUITINGUniversity of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, United States
RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
RECRUITING...and 74 more locations
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Free Eptinezumab Plasma Concentration
Time frame: 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])
Time frame: From randomization (Week 0) up to Week 20
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Time frame: From randomization (Week 0) up to Week 20