RECRUITING

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Official Title

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Quick Facts

Study Start:2023-06-08
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05897320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  1. * 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).
  2. * 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.
  3. * 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.
  4. * 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.

Contacts and Locations

Study Contact

Email contact via H. Lundbeck A/S
CONTACT
+45 36301311
LundbeckClinicalTrials@Lundbeck.com

Principal Investigator

Email contact via H. Lundbeck A/S
STUDY_DIRECTOR
LundbeckClinicalTrials@Lundbeck.com

Study Locations (Sites)

Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, 06905-1206
United States
Child Neurology of NW Florida
Gulf Breeze, Florida, 32561-4495
United States
A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida, 33012-3407
United States
University of South Florida
Tampa, Florida, 33612
United States
University of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, 40508-1683
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1544
United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104-5131
United States
North Suffolk Neurology-Commack
Commack, New York, 11725-2808
United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina, 28211-5027
United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, 44308-1063
United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, 45229-3026
United States
Road Runner Research Ltd
San Antonio, Texas, 78249-3539
United States
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia, 23510
United States
Childrens Hospital of Wisconsin
New Berlin, Wisconsin, 53151-7494
United States

Collaborators and Investigators

Sponsor: H. Lundbeck A/S

  • Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, LundbeckClinicalTrials@Lundbeck.com

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Episodic Migraine