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Eptinezumab for Childhood Migraine

Phase 1
Waitlist Available
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 from dosing to week 20
Awards & highlights

Study Summary

This trial will help researchers learn how eptinezumab affects the body when given intravenously.

Eligible Conditions
  • Childhood Migraine
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from dosing to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and from dosing to week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under curve (AUC) (0-infinity) eptinezumab
Cmax eptinezumab
Secondary outcome measures
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
Clearance (CL)
Development of anti-eptinezumab 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: EptinezumabExperimental Treatment1 Intervention
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
77,555 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
58,312 Total Patients Enrolled

Frequently Asked Questions

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

How many medical establishments are presently conducting this research project?

"The trial is being conducted across 15 different sites, three of which are based in Ann Arbor, Pittsburgh and West Palm Beach. If you choose to take part it would be beneficial for you to opt for the closest location available in order to minimize travel needs."

Answered by AI

Has Eptinezumab been declared suitable for public use by the FDA?

"The risk-benefit analysis conducted by Power assigned a score of 1 to eptinezumab due to its Phase 1 status, indicating that there is limited information on the medication's safety and efficacy."

Answered by AI

Are geriatric patients accepted in this medical trial?

"This study is open to children aged 6-17, and there are 35 slots available for minors. For those over the age of 65, 121 positions remain unoccupied."

Answered by AI

What is the total participant count for this clinical experiment?

"At this juncture, the research team is not currently seeking new participants for this trial which was first made public on August 3rd 2020. However, there are 172 migrain studies and 7 eptinezumab trials that are presently recruiting patients."

Answered by AI

Is this experimental procedure the inaugural instance of its type?

"Research into eptinezumab began in 2020 and a Phase 1 trial, sponsored by H. Lundbeck A/S was completed that same year. Following the successful completion of this initial study which included 28 participants, approval for the drug's use in clinical trials was granted. Currently, there are 7 active studies involving 130 cities across 25 countries."

Answered by AI

What additional research has been conducted to assess the efficacy of Eptinezumab?

"Currently, 7 trials investigating the effects of eptinezumab are underway with 6 in Phase 3. Although most are situated in Valladolid and Île-de-France, there exist 291 locations running research on this medication's efficacy."

Answered by AI

Is there an ongoing recruitment process for this trial?

"According to the documents on clinicaltrials.gov, this trial is no longer enlisting participants. The study was first posted in August of 2020 and last updated in November of 2022; however, 179 other trials remain open for recruitment."

Answered by AI

Is it possible to register for this clinical experiment?

"This medical study is in search of 28 individuals aged 6-17 who have had a migraine diagnosis, as defined by the International Classification of Headache Disorders (ICHD)-3 criteria, for at least six months prior to screening. Furthermore, participants must be experiencing four or more migraines per month over the three preceding months before being admitted into the trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~6 spots leftby Apr 2025