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NCT04537429
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
Completed
Phase 1
Last updated 6 October 2023
What this trial tests
Phase 1 trial testing Eptinezumab in Migraine in Children in 28 participants. Completed in 21 August 2023.
Timeline
4 August 2020
Primary endpoint
20 October 2022
20 October 2022
21 August 2023
Quick facts
| Lead sponsor | H. Lundbeck A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 4 August 2020 |
| Primary completion | 20 October 2022 |
| Estimated completion | 21 August 2023 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Eptinezumab (EPTINEZUMAB) — full drug profile →
Conditions studied
- Migraine in Children — all drugs for Migraine in Children →
- Migraine — all drugs for Migraine →
Sponsor
H. Lundbeck A/S — full company profile →
Who can join
Adults 6 to 17, any sex, with Migraine in Children or Migraine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.
Cohen F, Yuan H, Silberstein SD. · · 2022 · cited 28× · PMID 35476215 · DOI 10.1007/s40259-022-00530-0 -
The Arrival of Anti-CGRP Monoclonal Antibodies in Migraine.
Cohen F, Yuan H, DePoy EMG, Silberstein SD. · · 2022 · cited 28× · PMID 35426060 · DOI 10.1007/s13311-022-01230-x -
Eptinezumab for the preventive treatment of episodic and chronic migraine: a narrative review.
Irimia P, Santos-Lasaosa S, Pozo-Rosich P, Leira R, et al · · 2024 · cited 11× · PMID 38523607 · DOI 10.3389/fneur.2024.1355877 -
Emerging Pharmacological Treatments for Migraine in the Pediatric Population.
Iannone LF, De Cesaris F, Geppetti P. · · 2022 · cited 10× · PMID 35455026 · DOI 10.3390/life12040536 -
A Review of Eptinezumab Use in Migraine.
Datta A, Maryala S, John R. · · 2021 · cited 10× · PMID 34540516 · DOI 10.7759/cureus.18032 -
CGRP in Childhood and Adolescence Migraine: (Patho)physiological and Clinical Aspects.
Evers S. · · 2022 · cited 9× · PMID 35353359 · DOI 10.1007/s11916-022-01047-5 -
Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention.
Morgan KW, Joyner KR. · · 2021 · cited 4× · PMID 34659764 · DOI 10.1177/20503121211050186 -
Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine.
Hershey AD, Areberg J, Boserup LP, Lindsten A, et al · · 2025 · cited 2× · PMID 40444655 · DOI 10.1111/head.14959
Verify or expand the search:
- PubMed search for NCT04537429
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eptinezumab
Trials testing the same drug.
- NCT07191145 — Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT) · Phase 3 · not yet recruiting
- NCT07035197 — Facilitators and Barriers to Eptinezumab Administration in Thailand · completed
- NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
- NCT06428838 — Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context · Phase 3 · not yet recruiting
- NCT05897320 — A Study of Eptinezumab in Pediatric Participants With Episodic Migraine · Phase 3 · recruiting
Other recruiting trials for Migraine in Children
Currently open trials in the same condition.
- NCT06277063 — nVNS for the Prevention and Treatment of Primary Headache · NA · recruiting
- NCT06558578 — Association of Helicobacter Pylori Infection and Migraine · NA · recruiting
- NCT05814497 — Supraspinal Processing of Sensory Aspects of Pain · NA · recruiting
Other H. Lundbeck A/S trials
Trials by the same sponsor.
- NCT07514858 — A Trial Investigating Lu AF28996 in Adults With Parkinson's Disease Who Have Motor Fluctuations · Phase 2 · not yet recruiting
- NCT07513441 — A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD) · Phase 1 · not yet recruiting
- NCT06701526 — A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications · Phase 4 · active not recruiting
- NCT06706622 — A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) · Phase 3 · active not recruiting
- NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04537429 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lundbeck A/S
- Last refreshed: 6 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04537429.
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