A Study of Eptinezumab in Pediatric Participants With Episodic Migraine (PROSPECT-1)

February 7, 2024 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 5L5
        • Recruiting
        • Medical Arts Health Research Group - Penticton
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Recruiting
        • The Kids Clinic
  • Italy
    • Liguria
      • Genova, Liguria, Italy, 16147
        • Recruiting
        • Istituto G Gaslini Ospedale Pediatrico IRCCS
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milano, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Mondino IRCCS
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Recruiting
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana-Via Roma 67
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Hospital de Braga
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • Hospital Pediatrico de Coimbra
      • Lisboa, Portugal, 1998-018
        • Recruiting
        • Hospital Cuf Descobertas
    • Setúbal
      • Porto Covo, Setúbal, Portugal, 4050-651
        • Recruiting
        • Centro Materno Infantil do Norte
  • Spain
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • CHUVI - H.U. Alvaro Cunqueiro
  • United Kingdom
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G514TF
        • Recruiting
        • Royal Hospital for Children (Glasgow) - PPDS - PIN
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust
  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 06905-1206
        • Recruiting
        • Ki Health Partners LLC DBA New England Institute for Clinical Research
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4495
        • Recruiting
        • Child Neurology of NW Florida
      • Hialeah, Florida, United States, 33012-3407
        • Recruiting
        • A G A Clinical Trials - HyperCore - PPDS
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Recruiting
        • University of Maryland School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Recruiting
        • Michigan Head Pain and Neurological Institute
    • New York
      • Commack, New York, United States, 11725-2808
        • Recruiting
        • North Suffolk Neurology-Commack
    • North Carolina
      • Charlotte, North Carolina, United States, 28211-5027
        • Recruiting
        • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
    • Texas
      • San Antonio, Texas, United States, 78249-3539
        • Recruiting
        • Road Runner Research Ltd
    • Virginia
      • Norfolk, Virginia, United States, 23510-1021
        • Recruiting
        • Children's Specialty Group

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Drug: Eptinezumab
Solution for infusion
Experimental: Eptinezumab 300 mg
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Drug: Eptinezumab
Solution for infusion
Placebo Comparator: Placebo
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Drug: Placebo
Solution for infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, 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 Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19357A
  • 2022-502538-14-00 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Episodic Migraine

Clinical Trials on Eptinezumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe