A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
H. Lundbeck A/S · NCT05897320
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 315
- US sites recruiting
- 9
- Study start
- June 8, 2023
- Record last updated
- October 14, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Being studied: Eptinezumab; Placebo
Conditions: Episodic Migraine
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
- During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
- During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
Exclusion Criteria
- History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
- History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
- Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
Recruiting US locations
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, CT 06905-1206
Child Neurology Center (CNC) of Northwest Florida
Gulf Breeze, FL 32561-4458
AGA Clinical Trials
Hialeah, FL 33012-3407
University of South Florida (USF) - Tampa Campus
Tampa, FL 33620
Akron Children's Hospital
Akron, OH 44308-1062
Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, OH 45229-3026
Road Runner Research (RRR)
San Antonio, TX 78249-3539
Children's Specialty Group (CSG)
Norfolk, VA 23507
Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus
Milwaukee, WI 53226
Study contacts (from the official record)
- Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com
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