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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 baseline, weeks 8, 12, 24, 36, and 44
Awards & highlights

REJOIN Trial 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.Check my eligibility
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.See study design
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.

REJOIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 8, 12, 24, 36, and 44
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 8, 12, 24, 36, and 44 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events
Secondary outcome measures
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
Free Eptinezumab Plasma Concentration
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
+1 more

Side effects data

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

REJOIN 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
~2040

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
76,983 Total Patients Enrolled
12 Trials studying Migraine
4,186 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
57,740 Total Patients Enrolled
11 Trials studying Migraine
3,688 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a full clinical trial or are there still opportunities for new participants?

"That is correct. Based on the information available on clinicaltrials.gov, this particular trial is currently looking for 610 individuals to participate. The trial was originally posted on December 1st, 2021 and the most recent update was on October 10th, 2022. There are 4 different locations where the trial is taking place."

Answered by AI

Have other groups conducted similar research in the past?

"7 different clinical trials for Eptinezumab are currently underway in 25 countries and 125 cities. The first trial, conducted in 2020, completed its Phase 1 drug approval stage. It was sponsored by H. Lundbeck A/S and involved 32 participants. Since then, 10 more Eptinezumab studies have been completed."

Answered by AI

Are octogenarians eligible for participation in this experiment?

"The age range for patients that this study is recruiting is between 6-17 years old."

Answered by AI

What other research has been published on Eptinezumab?

"There are currently 7 clinical trials underway for eptinezumab. Of these, 6 are in phase 3. Many of the studies are based in Novosibirsk and England, but there are 283 total locations where research is being conducted."

Answered by AI

Are there hospitals outside of Canada testing this treatment?

"There are 4 primary sites running this trial, with Charlotte, Amherst, and Loxahatchee Groves being the most prominent. To limit participant inconvenience, please try and select the site closest to your location."

Answered by AI

How many individuals are being given this treatment as part of the trial?

"In order to carry out this experiment,610 participants that meet the specific inclusion criteria are required. The sponsor, H. Lundbeck A/S, has chosen different medical sites to carry out the trial, such as OnSite Clinical Solutions, LLC - ClinEdge - PPDS in Charlotte, North carolina and Dent Neurosciences Research Center Incorporated in Amherst, New york."

Answered by AI

When can patients expect Eptinezumab to be available for purchase?

"Eptinezumab is a Phase 3 medication, meaning that while there is some data to support its efficacy, there is also extensive data confirming its safety. Therefore, it received a score of 3."

Answered by AI

Am I able to join this clinical trial?

"This trial is for children and adolescents aged 6 to 17 who have previously completed a study on migraines. Up to 610 patients will be enrolled, and they must have completed the prior study within the last 12 weeks."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
2021. "A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05164172.
All > Migraine Headaches > Migraine
~213 spots leftby Sep 2025
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