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The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | up to four iv infusions of eptinezumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) (0-infinity) eptinezumab | Area under the plasma concentration curve for eptinezumab from zero to infinity | From dosing to week 20 |
| Cmax eptinezumab | Maximum observed plasma concentration of eptinezumab | From dosing to week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) | Plasma clearance | From dosing to week 20 |
| Volume of distribution (Vz) | From dosing to week 20 | |
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Inclusion Criteria:
Exclusion Criteria:
Other in- and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States | ||
| NW FL Clinical Research Group LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40444655 | Derived | Hershey AD, Areberg J, Boserup LP, Lindsten A, Rosen M. Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine. Headache. 2025 Oct;65(9):1573-1583. doi: 10.1111/head.14959. Epub 2025 May 30. |
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| 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 |
| Gulf Breeze |
| Florida |
| 32561 |
| United States |
| The Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407-3234 | United States |
| College Park Family Care Center | Overland Park | Kansas | 66212 | United States |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Preferred Primary Care Physicians Inc. | Pittsburgh | Pennsylvania | 15236-4604 | United States |
| North Texas Institute of Neurology & Headache | Frisco | Texas | 75034 | United States |
| Road Runner Research Ltd | San Antonio | Texas | 78249 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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