A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Migraine
- Migraine in Children
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 17 years
- Gender
- Both males and females
Description
This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B). The main study period includes a single IV infusion of eptinezumab. The optional extension pe...
This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B). The main study period includes a single IV infusion of eptinezumab. The optional extension period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended dosing interval in adults), for a total of up to 4 infusions over the course of the study. At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16 patients aged 12 to 17 years, inclusive.
Tracking Information
- NCT #
- NCT04537429
- Collaborators
- Not Provided
- Investigators
- Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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