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Monoclonal Antibodies

Eptinezumab for Pediatric Migraine (REJOIN Trial)

Phase 3
Recruiting
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will investigate the safety of eptinezumab in children and adolescents with chronic or episodic migraines.

Who is the study for?
This trial is for children and adolescents aged 6 to 17 who suffer from chronic or episodic migraine and have completed a previous related study. They cannot join if they had severe reactions to the earlier treatment, significant liver test abnormalities, or other safety concerns as determined by the investigator.
What is being tested?
The focus of this study is on evaluating the long-term safety of a medication called Eptinezumab in young patients with migraines. It's an extension of prior studies where participants continue their treatment.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions like those seen in previous studies, which could range from mild to severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083
2%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Eptinezumab 300 mgExperimental Treatment1 Intervention
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Group II: Eptinezumab 100 mgExperimental Treatment1 Intervention
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
2021
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
329 Previous Clinical Trials
77,097 Total Patients Enrolled
14 Trials studying Migraine
4,276 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
189 Previous Clinical Trials
57,729 Total Patients Enrolled
12 Trials studying Migraine
3,676 Patients Enrolled for Migraine

Media Library

Eptinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05164172 — Phase 3
Migraine Research Study Groups: Eptinezumab 300 mg, Eptinezumab 100 mg
Migraine Clinical Trial 2023: Eptinezumab Highlights & Side Effects. Trial Name: NCT05164172 — Phase 3
Eptinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05164172 — Phase 3
~120 spots leftby Sep 2025
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