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NCT Number: NCT05897320

A Study of Eptinezumab in Pediatric Participants With 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.

Recruiting

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Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clínica Privada Independencia, Munro, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab

Drug

Solution for infusion

Placebo

Drug

Solution for infusion

Primary outcomes

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

    Time frame: Baseline, Weeks 1-12

Secondary outcomes

  1. Response: ≥50% Reduction From Baseline in MMDs

    Time frame: Baseline, Weeks 1-4 and Weeks 1-12

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

    Time frame: On Day After Dosing

  3. Change From Baseline in MMDs with Acute Medication Use

    Time frame: Baseline, Weeks 1-12

  4. Response: ≥75% reduction from baseline in MMDs

    Time frame: Baseline, Weeks 1-4 and Weeks 1-12

  5. Change From Baseline in the Number of Monthly Headache Days (MHDs)

    Time frame: Baseline, Weeks 1-12

  6. Change From Baseline in Monthly Hours with Headache

    Time frame: Baseline, Weeks 1-12

  7. Change From Baseline in Days with Acute Medication

    Time frame: Baseline, Weeks 1-12

  8. Change From Baseline in Rate of Migraines with Severe Pain Intensity

    Time frame: Baseline, Weeks 1-12

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

    Time frame: Baseline, Week 12

  10. Free Eptinezumab Plasma Concentrations

    Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20

  11. 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

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Email contact via H. Lundbeck A/S

CONTACT

[email protected]

+45 36301311

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Acronym: PROSPECT-1

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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