Migraine, Migraine in Children
Conditions
Brief summary
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
Detailed 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.
Interventions
DRUGEptinezumab
up to four iv infusions of eptinezumab
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under curve (AUC) (0-infinity) eptinezumab | From dosing to week 20 | Area under the plasma concentration curve for eptinezumab from zero to infinity |
| Cmax eptinezumab | From dosing to week 20 | Maximum observed plasma concentration of eptinezumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance (CL) | From dosing to week 20 | Plasma clearance |
| Volume of distribution (Vz) | From dosing to week 20 | — |
| Development of anti-eptinezumab antibodies (ADA) | From screening to week 12 | — |
| Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb) | From screening to week 12 | — |
Countries
United States
Outcome results
None listed