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/S
Summary
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
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 migra…
Interventions
- DrugEptinezumab
Solution for infusion
- DrugPlacebo
Solution for infusion
Locations (65)
- Ki Health Partners LLC DBA New England Institute for Clinical ResearchStamford, Connecticut
- Child Neurology of NW FloridaGulf Breeze, Florida
- AGA Clinical TrialsHialeah, Florida
- University of South Florida - 13330 USF Laurel DrTampa, Florida
- Clinical Integrative Research Center of AtlantaAtlanta, Georgia
- University of Kentucky HealthCare (UKHC) Kentucky ClinicLexington, Kentucky