Eptinezumab for Chronic Migraine in Children

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Migraine in ChildrenEptinezumab - Drug
Eligibility
12 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether eptinezumab is better than placebo at reducing the number of days with migraine in young people with chronic migraine.

Eligible Conditions
  • Chronic Migraine in Children

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)

Week 1
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Week 1
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Baseline, Weeks 1-12
Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
Day 1
Percentage of Participants With Migraine on the Day After Dosing (Day 1)
Week 20
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Week 20
Free Eptinezumab Plasma Concentration

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Eptinezumab
2%Hypersensitivity
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT04152083) in the Eptinezumab ARM group. Side effects include: Hypersensitivity with 2%.

Trial Design

3 Treatment Groups

Eptinezumab 300 mg
1 of 3
Eptinezumab 100 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

285 Total Participants · 3 Treatment Groups

Primary Treatment: Eptinezumab · Has Placebo Group · Phase 3

Eptinezumab 300 mg
Drug
Experimental Group · 1 Intervention: Eptinezumab · Intervention Types: Drug
Eptinezumab 100 mg
Drug
Experimental Group · 1 Intervention: Eptinezumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: randomization ( pre-dose [week 0]), week 8, week 12, and safety follow up visit (week 20)

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
317 Previous Clinical Trials
76,326 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
184 Previous Clinical Trials
57,662 Total Patients Enrolled

Eligibility Criteria

Age 12 - 17 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The participant must complete the headache eDiary on at least 24 of the 28 days following the screening visit.
The participant must have at least 15 headache days, including at least 8 migraine days, during the 28-day screening period.
The participant has a history of migraine headaches lasting at least 6 months.