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NCT Number: NCT05164172

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

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.

Recruiting

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Privado de La Comunidad, Mar del Plata, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab

Drug

Concentrate for solution for infusion

Other names: Vyepti

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events

    Time frame: Baseline up to Week 44

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Email contact via H. Lundbeck A/S

CONTACT

[email protected]

+45 36301311

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Acronym: REJOIN

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 20, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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