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Trial record 1 of 1 for:    2020-001649-38
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A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

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ClinicalTrials.gov Identifier: NCT05164172
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Eptinezumab Phase 3

Detailed Description:
This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eptinezumab 300 mg
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
 Drug: Eptinezumab
Concentrate for solution for infusion
Other Name: Vyepti
Experimental: Eptinezumab 100 mg
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
 Drug: Eptinezumab
Concentrate for solution for infusion
Other Name: Vyepti


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: Baseline up to Week 44 ]

Secondary Outcome Measures :
  1. Free Eptinezumab Plasma Concentration [ Time Frame: Baseline, Weeks 8, 12, 24, 36, and 44 ]
  2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [ Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 ]
  3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) [ Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 ]
  4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36 [ Time Frame: Baseline, Weeks 12, 24, and 36 ]
  5. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  6. Change From Baseline in Monthly Migraine Days Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]
  7. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]

Eligibility Criteria
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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 participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion Criteria:

  • The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
  • During lead-in Study19356A or Study19357A:
  • participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
  • the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later.
  • the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.
Contacts and Locations
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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): NCT05164172


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
Ki Health Partners LLC DBA New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905-1206
United States, Florida
A G A Clinical Trials - HyperCore - PPDS Recruiting
Hialeah, Florida, United States, 33012-3402
Axcess Medical Research Recruiting
Loxahatchee Groves, Florida, United States, 33470-9272
United States, Michigan
Michigan Head Pain and Neurological Institute Recruiting
Ann Arbor, Michigan, United States, 48104-5131
United States, New York
Dent Neurosciences Research Center Incorporated Recruiting
Amherst, New York, United States, 14226-1727
United States, North Carolina
OnSite Clinical Solutions, LLC - ClinEdge - PPDS Recruiting
Charlotte, North Carolina, United States, 28226-8380
Argentina
Hospital Privado de La Comunidad Recruiting
Mar Del Plata, Buenos Aires, Argentina, 7603
Hospital de Niños de La Santisima Trinidad Recruiting
Cordoba-Barrio Crisol, Cordoba, Argentina, X5014AKM
Centro de Investigaciones Médicas Tucuman Recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Mexico
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44700
Clinical Research Institute Recruiting
Ampl San Lucas Tepetlacalco, México, Mexico, 54055
Instituto de Investigationes Clinicas para la Salud A.C. Recruiting
Durango, Mexico, 34000
Spain
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S H. Lundbeck A/S
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT05164172    
Other Study ID Numbers: 19379A
2020-001649-38 ( EudraCT Number )
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023

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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