ClinicalTrials.Veeva

Menu
The trial is taking place at:
R

Road Runner Research, Ltd | San Antonio, TX

Veeva-enabled site

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

Lundbeck logo

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

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

Trial contacts and locations

41

Loading...

Central trial contact

Email contact via H. Lundbeck A/S

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems