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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897320
Collaborator
(none)
315
Enrollment
3
Arms
16.8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
315 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 9, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Experimental: Eptinezumab 100 mg

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

Drug: Eptinezumab
Solution for infusion

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Response: ≥50% Reduction From Baseline in MMDs [Baseline, Weeks 1-4 and Weeks 1-12]

  2. Percentage of Participants with Migraine on the Day After Dosing (Day 1) [On Day After Dosing]

  3. Change From Baseline in MMDs with Acute Medication Use [Baseline, Weeks 1-12]

  4. Response: ≥75% reduction from baseline in MMDs [Baseline, Weeks 1-4 and Weeks 1-12]

  5. Change From Baseline in the Number of Monthly Headache Days (MHDs) [Baseline, Weeks 1-12]

  6. Change From Baseline in Monthly Hours with Headache [Baseline, Weeks 1-12]

  7. Change From Baseline in Days with Acute Medication [Baseline, Weeks 1-12]

  8. Change From Baseline in Rate of Migraines with Severe Pain Intensity [Baseline, Weeks 1-12]

  9. Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score [Baseline, Week 12]

  10. Free Eptinezumab Plasma Concentrations [Day 0 (pre-dose) and at Weeks 8, 12, and 20]

  11. Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [Day 0 (pre-dose) and at Weeks 8, 12, and 20]

  12. Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) [Day 0 (pre-dose) and at Weeks 8, 12, and 20]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT05897320
Other Study ID Numbers:
  • 19357A
  • 2022-502538-14-00
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Migraine Disorders

Study Results

No Results Posted as of Jun 9, 2023