A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Episodic Migraine Clinical Trial

— PROSPECT-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897320
• Other study ID #: 19357A
• Secondary ID: 2022-502538-14-0
• Status: Recruiting
• Phase: Phase 3
• Start date: June 8, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Eptinezumab
Solution for infusion
• Placebo
Solution for infusion

Locations

Country	Name	City	State
Argentina	INECO Neurociencias Orono	Rosario	Santa Fe
Canada	The Kids Clinic	Ajax	Ontario
Canada	Medical Arts Health Research Group - Penticton	Penticton	British Columbia
Italy	Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN	Firenze	Toscana
Italy	Istituto G Gaslini Ospedale Pediatrico IRCCS	Genova	Liguria
Italy	Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia
Italy	Fondazione Istituto Neurologico Mondino IRCCS	Pavia	Lombardia
Italy	Azienda Ospedaliero Universitaria Pisana-Via Roma 67	Pisa	Toscana
Portugal	Hospital de Braga	Braga
Portugal	Hospital Pediatrico de Coimbra	Coimbra
Portugal	Hospital CUF Descobertas	Lisboa
Portugal	Centro Materno Infantil do Norte	Porto Covo	Setúbal
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	CHUVI - H.U. Alvaro Cunqueiro	Vigo	Pontevedra
United Kingdom	Royal Hospital for Children (Glasgow) - PPDS - PIN	Glasgow	Glasgow City
United Kingdom	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth	Norfolk
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS	Charlotte	North Carolina
United States	North Suffolk Neurology-Commack	Commack	New York
United States	Child Neurology of NW Florida	Gulf Breeze	Florida
United States	A G A Clinical Trials - HyperCore - PPDS	Hialeah	Florida
United States	Children's Specialty Group	Norfolk	Virginia
United States	Road Runner Research Ltd	San Antonio	Texas
United States	Ki Health Partners LLC DBA New England Institute for Clinical Research	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12		Baseline, Weeks 1-12
Secondary	Response: =50% Reduction From Baseline in MMDs		Baseline, Weeks 1-4 and Weeks 1-12
Secondary	Percentage of Participants with Migraine on the Day After Dosing (Day 1)		On Day After Dosing
Secondary	Change From Baseline in MMDs with Acute Medication Use		Baseline, Weeks 1-12
Secondary	Response: =75% reduction from baseline in MMDs		Baseline, Weeks 1-4 and Weeks 1-12
Secondary	Change From Baseline in the Number of Monthly Headache Days (MHDs)		Baseline, Weeks 1-12
Secondary	Change From Baseline in Monthly Hours with Headache		Baseline, Weeks 1-12
Secondary	Change From Baseline in Days with Acute Medication		Baseline, Weeks 1-12
Secondary	Change From Baseline in Rate of Migraines with Severe Pain Intensity		Baseline, Weeks 1-12
Secondary	Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score		Baseline, Week 12
Secondary	Free Eptinezumab Plasma Concentrations		Day 0 (pre-dose) and at Weeks 8, 12, and 20
Secondary	Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])		Day 0 (pre-dose) and at Weeks 8, 12, and 20
Secondary	Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)		Day 0 (pre-dose) and at Weeks 8, 12, and 20