A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Conditions

• Chronic Migraine in Children

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Eptinezumab — DRUG
  Eptinezumab will be administered per dose and schedule specified in the arm.
• Placebo — DRUG
  Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Study Details

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Key Dates

Start date

Jun 30, 2021

Status verified

May 2026

Primary completion

Sep 5, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

285 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Eptinezumab 300 mg
  Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).
• Experimental: Eptinezumab 100 mg
  Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
• Placebo Comparator: Placebo
  Participants will receive a single IV infusion of placebo matching to eptinezumab.

Primary Outcome Measure

Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]

Central Contacts

• Email contact via H. Lundbeck A/S
  +45 36301311
  [email protected]

Locations (22)

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