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Monoclonal Antibodies

Eptinezumab for Pediatric Migraine (PROSPECT-1 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

Summary

This trial tests if a drug can reduce migraine days for kids with episodic migraines.

Who is the study for?
This trial is for kids with episodic migraines, diagnosed per international standards, who've had migraines for at least 6 months. They must have tracked their headaches in an eDiary during the screening period. It's not for those with severe head trauma, other major neurological disorders, unusual migraine types like hemiplegic migraine or if they have uncontrolled psychiatric conditions.
What is being tested?
The study aims to find out if Eptinezumab can reduce the number of days children experience episodic migraines compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Eptinezumab or the placebo.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with migraine medications include reactions at the injection site, nausea, fatigue and allergic reactions. The exact side effects of Eptinezumab in children will be monitored throughout the trial.

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.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Eptinezumab 300 mgExperimental Treatment1 Intervention
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Group II: Eptinezumab 100 mgExperimental Treatment1 Intervention
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single IV infusion of matching placebo to eptinezumab.
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
77,394 Total Patients Enrolled
15 Trials studying Migraine
4,876 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
189 Previous Clinical Trials
58,014 Total Patients Enrolled
13 Trials studying Migraine
4,276 Patients Enrolled for Migraine

Media Library

Eptinezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05897320 — Phase 3
Migraine Research Study Groups: Eptinezumab 300 mg, Placebo, Eptinezumab 100 mg
Migraine Clinical Trial 2023: Eptinezumab Highlights & Side Effects. Trial Name: NCT05897320 — Phase 3
Eptinezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05897320 — Phase 3
~130 spots leftby Nov 2025
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