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
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
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.
Inclusion Criteria:
Exclusion Criteria:
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Stamford, Connecticut 06905, United States
Washington D.C., District of Columbia 20010-2916, United States
Atlanta, Georgia 30328-5574, United States
Lexington, Kentucky 40508-1683, United States
Baltimore, Maryland 21201-1595, United States
Charlotte, North Carolina 28211-5027, United States
Cincinnati, Ohio 45229-3026, United States
Oklahoma City, Oklahoma 73104, United States
Huntington, West Virginia 25701-3656, United States
Córdoba-Barrio Crisol, Córdoba Province X5014AKM, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
Buenos Aires, C1181ACH, Argentina
Penticton, British Columbia V2A 5L5, Canada
Victoria, British Columbia V8R 1J8, Canada
Pavia, Apulia 27100, Italy
Pavia, Lombardy 27100, Italy
Cagliari, Sardinia 09121, Italy
Pavia, Tuscany 27100, Italy
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Morelia, Michoacán 58260, Mexico
México, State of Mexico 14050, Mexico
Krakow, Lesser Poland Voivodeship 30-363, Poland
Oświęcim, Lesser Poland Voivodeship 32-600, Poland
Wroclaw, Lower Silesian Voivodeship 52-210, Poland
Almada, Setúbal District 2805-267, Portugal
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Eskişehir, 26480, Turkey (Türkiye)
Fatih/Istanbul, 34093, Turkey (Türkiye)
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Edinburgh, Midlothian EH16 4TJ, United Kingdom
Great Yarmouth, Norfolk NR31 6LA, United Kingdom
Glasgow, North Lanarkshire G51 4TF, United Kingdom