A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
H. Lundbeck A/S
Study ID
NCT05164172
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Eptinezumab — DRUG
    Concentrate for solution for infusion

Study Details

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Key Dates

Start date
Dec 1, 2021
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Eptinezumab 300 mg
    Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
  • Experimental: Eptinezumab 100 mg
    Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events [ Time Frame: Baseline up to Week 44 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06511-
Ki Health Partners LLC DBA New England Institute for Clinical ResearchStamfordConnecticut06905-1206-
NW FL Clinical Research Group, LLCGulf BreezeFlorida32561-4458-
AGA Clinical Trials - Hialeah - 4980 W 10th AveHialeahFlorida33012-
Axcess Medical ResearchLoxahatchee GrovesFlorida33470-9272-
University of South FloridaTampaFlorida33612-6601-
University of KentuckyLexingtonKentucky40536-7001-
University of Maryland School of MedicineBaltimoreMaryland21201-1544-
Michigan Head Pain and Neurological InstituteAnn ArborMichigan48104-5131-
Michigan State University - Department of NeurologyEast LansingMichigan48824-7015-
Helen Devos Childrens' Hospital - PINGrand RapidsMichigan49503-2528-
Dent Neurosciences Research Center IncorporatedAmherstNew York14226-1727-
True North NeurologyCommackNew York11725-2808-
OnSite Clinical Solutions, LLC - Randolph Rd - CharlotteCharlotteNorth Carolina28211-5027-
Childrens Hospital Medical Center of AkronAkronOhio44308-1063-
Cincinnati Children's Hospital Medical Center - PINCincinnatiOhio45229-3026-
Road Runner Research LtdSan AntonioTexas78249-3539-
Children's Specialty Group - 3 Commercial PlaceNorfolkVirginia23510-
Marshall University Medical CenterHuntingtonWest Virginia25701-3656-
Children's Wisconsin - Milwaukee Campus - PINMilwaukeeWisconsin53226-

Find similar trials in New Haven, CT

By condition
Migraine
By specialty
Neurology
By research site
Yale University School of Medicine· New Haven, CTKi Health Partners LLC DBA New England Institute for Clinical Research· Stamford, CTNW FL Clinical Research Group, LLC· Gulf Breeze, FLAGA Clinical Trials - Hialeah - 4980 W 10th Ave· Hialeah, FLAxcess Medical Research· Loxahatchee Groves, FLUniversity of South Florida· Tampa, FL

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