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A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537429
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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.

Condition or disease Intervention/treatment Phase
Migraine in Children Migraine Drug: Eptinezumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Eptinezumab Drug: Eptinezumab
up to four iv infusions of eptinezumab




Primary Outcome Measures :
  1. Area under curve (AUC) (0-infinity) eptinezumab [ Time Frame: From dosing to week 20 ]
    Area under the plasma concentration curve for eptinezumab from zero to infinity

  2. Cmax eptinezumab [ Time Frame: From dosing to week 20 ]
    Maximum observed plasma concentration of eptinezumab


Secondary Outcome Measures :
  1. Clearance (CL) [ Time Frame: From dosing to week 20 ]
    Plasma clearance

  2. Volume of distribution (Vz) [ Time Frame: From dosing to week 20 ]
  3. Development of anti-eptinezumab antibodies (ADA) [ Time Frame: From screening to week 12 ]
  4. Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb) [ Time Frame: From screening to week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537429


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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United States, Connecticut
New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
United States, Florida
NW FL Clinical Research Group LLC Recruiting
Gulf Breeze, Florida, United States, 32561
The Premiere Research Institute at Palm Beach Neurology Recruiting
West Palm Beach, Florida, United States, 33407-3234
United States, Kansas
College Park Family Care Center Recruiting
Overland Park, Kansas, United States, 66212
United States, Michigan
Michigan Head Pain and Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Pennsylvania
Preferred Primary Care Physicians Inc. Recruiting
Pittsburgh, Pennsylvania, United States, 15236-4604
United States, Texas
Road Runner Research Ltd Recruiting
San Antonio, Texas, United States, 78249
United States, Utah
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04537429    
Other Study ID Numbers: 18922A
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases