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

Lundbeck

Status and phase: Enrolling; Phase 3

Conditions: Episodic Migraine

Treatments: Drug: Placebo; Drug: Eptinezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05897320

2022-502538-14-00 (Other Identifier)

19357A

Details and patient eligibility

About

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

Enrollment: 315 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 3 patient groups, including a placebo group

Eptinezumab 300 mg

Experimental group

Description:

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

Treatment:

Drug: Eptinezumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Eptinezumab 100 mg

Experimental group

Description:

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

Treatment:

Drug: Eptinezumab