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
H. Lundbeck A/S
Summary
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.
Description
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.
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
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:…
Interventions
- DrugEptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
- DrugPlacebo
Placebo matching to eptinezumab will be administered per schedule specified in the arm.
Locations (84)
- Yale-New Haven Children's Hospital - PINNew Haven, Connecticut
- Ki Health Partners LLC DBA New England Institute for Clinical ResearchStamford, Connecticut
- Children's National Medical CenterWashington D.C., District of Columbia
- NW FL Clinical Research Group, LLCGulf Breeze, Florida
- AGA Clinical TrialsHialeah, Florida
- Axcess Medical ResearchLoxahatchee Groves, Florida