A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
H. Lundbeck A/S
Study ID
NCT05897320
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Eptinezumab — DRUG
    Solution for infusion
  • Placebo — DRUG
    Solution for infusion

Study Details

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

Key Dates

Start date
Jun 8, 2023
Status verified
Mar 2026
Primary completion
Jul 6, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Ki Health Partners LLC DBA New England Institute for Clinical ResearchStamfordConnecticut06905-1206-
Child Neurology of NW FloridaGulf BreezeFlorida32561-4495-
AGA Clinical TrialsHialeahFlorida33012-
University of South Florida - 13330 USF Laurel DrTampaFlorida33620-
Clinical Integrative Research Center of AtlantaAtlantaGeorgia30328-6191-
University of Kentucky HealthCare (UKHC) Kentucky ClinicLexingtonKentucky40508-1683-
University of Maryland School of MedicineBaltimoreMaryland21201-1544-
Michigan Head Pain and Neurological InstituteAnn ArborMichigan48104-5131-
North Suffolk Neurology-CommackCommackNew 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-
Childrens Hospital of Wisconsin - PINNew BerlinWisconsin53151-7494-

Find similar trials in Stamford, CT

By condition
Migraine
By specialty
Neurology
By research site
Ki Health Partners LLC DBA New England Institute for Clinical Research· Stamford, CTChild Neurology of NW Florida· Gulf Breeze, FLAGA Clinical Trials· Hialeah, FLUniversity of South Florida - 13330 USF Laurel Dr· Tampa, FLClinical Integrative Research Center of Atlanta· Atlanta, GAUniversity of Kentucky HealthCare (UKHC) Kentucky Clinic· Lexington, KY

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