A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
Full 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 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- The patient has a diagnosis of migraine with or without aura according to international classification of headache disorders (ICHD)-3 (in the opinion of the investigator) for ≥6 months prior to the Screening Visit and has a frequency of migraine ≥4 migraine days per month for at least 3 months prior to the Screening Visit.
Exclusion criteria
- The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the Screening Visit.
Other in- and exclusion criteria may apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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