Clinical trial
An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents With Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period
Name
18922A
Description
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
Trial arms
Trial start
2020-08-04
Estimated PCD
2022-10-20
Trial end
2023-08-21
Status
Completed
Phase
Early phase I
Treatment
Eptinezumab
up to four iv infusions of eptinezumab
Arms:
Eptinezumab
Size
28
Primary endpoint
Area under curve (AUC) (0-infinity) eptinezumab
From dosing to week 20
Cmax eptinezumab
From dosing to week 20
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}
Updated at
2023-10-06
1 organization
1 product
1 indication
Organization
H. LundbeckProduct
EptinezumabIndication
Migraine