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

Primary Purpose

Episodic Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Child Neurology of NW FloridaRecruiting
  • A G A Clinical Trials - HyperCore - PPDSRecruiting
  • Michigan Head Pain and Neurological InstituteRecruiting
  • OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDSRecruiting
  • The Kids ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Eptinezumab 300 mg

Placebo

Eptinezumab 100 mg

Arm Description

Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

Participants will receive a single IV infusion of matching placebo to eptinezumab.

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2023
Last Updated
October 9, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05897320
Brief Title
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eptinezumab 300 mg
Arm Type
Experimental
Arm Description
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Arm Title
Eptinezumab 100 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
Solution for infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Time Frame
Baseline, Weeks 1-12
Secondary Outcome Measure Information:
Title
Response: ≥50% Reduction From Baseline in MMDs
Time Frame
Baseline, Weeks 1-4 and Weeks 1-12
Title
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Time Frame
On Day After Dosing
Title
Change From Baseline in MMDs with Acute Medication Use
Time Frame
Baseline, Weeks 1-12
Title
Response: ≥75% reduction from baseline in MMDs
Time Frame
Baseline, Weeks 1-4 and Weeks 1-12
Title
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time Frame
Baseline, Weeks 1-12
Title
Change From Baseline in Monthly Hours with Headache
Time Frame
Baseline, Weeks 1-12
Title
Change From Baseline in Days with Acute Medication
Time Frame
Baseline, Weeks 1-12
Title
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Time Frame
Baseline, Weeks 1-12
Title
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time Frame
Baseline, Week 12
Title
Free Eptinezumab Plasma Concentrations
Time Frame
Day 0 (pre-dose) and at Weeks 8, 12, and 20
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Email contact via H. Lundbeck A/S
Phone
+45 36301311
Email
LundbeckClinicalTrials@Lundbeck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Child Neurology of NW Florida
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4495
Country
United States
Individual Site Status
Recruiting
Facility Name
A G A Clinical Trials - HyperCore - PPDS
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-3407
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Individual Site Status
Recruiting
Facility Name
OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDS
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211-5027
Country
United States
Individual Site Status
Recruiting
Facility Name
The Kids Clinic
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

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