Episodic MigrainePhase 3PROSPECT-1NCT05897320
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
A Phase 3 study testing Eptinezumab in people with Episodic Migraine, run by H. Lundbeck A/S at 60 sites in 11 countries.
Trial summary
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 60 sitesin 11 countries
- Study dates
- 8 Jun 2023to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
60 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 11 countries
United States15 sites, 9 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308-1062
- Completed
Michigan Headache & Neurological Institute (MHNI)
Ann Arbor, Michigan, 48104-5131
- Completed
Clinical Integrative Research Center of Atlanta (CIRCAtl)
Atlanta, Georgia, 30328-5574
- Completed
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1509
- Completed
OnSite Clinical Solutions, LLC - Charlotte
Charlotte, North Carolina, 28210-0106
- Recruiting
Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio, 45229-3026
- Completed
True North Neurology - Commack (North Suffolk Neurology)
Commack, New York, 11725-2850
- Recruiting
Child Neurology Center (CNC) of Northwest Florida
Gulf Breeze, Florida, 32561-4458
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012-3407
- Completed
UK HealthCare-Kentucky Clinic
Lexington, Kentucky, 40536
- Recruiting
Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus
Milwaukee, Wisconsin, 53226
- Recruiting
Children's Specialty Group (CSG)
Norfolk, Virginia, 23507
- Recruiting
Road Runner Research (RRR)
San Antonio, Texas, 78249-3539
- Recruiting
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, Connecticut, 06905-1206
- Recruiting
University of South Florida (USF) - Tampa Campus
Tampa, Florida, 33620
Argentina7 sites, 4 recruiting
- Completed
Mautalén Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF
- Completed
Clinica Independencia
Buenos Aires, 1605
- Completed
Hospital Britanico de Buenos Aires (HOB)
Buenos Aires, C1280AEB
- Recruiting
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province, X5014AKM
- Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800
- Recruiting
INECO Neurociencias Oroño
Rosario, Santa Fe Province, S2000DTP
- Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL
Italy6 sites, 4 recruiting
- Completed
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...
Cagliari, South Sardinia, 09121
- Recruiting
Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare
Genoa, 16147
- Completed
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133
- Recruiting
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
Pavia, 27100
- Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...
Pisa, 56126
- Recruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo
Rome, 00165
Poland5 sites, 5 recruiting
- Recruiting
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
- Recruiting
ETG Lublin
Lublin, Lublin Voivodeship, 20-412
- Recruiting
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k
Oświęcim, Lesser Poland Voivodeship, 32-600
- Recruiting
MTZ Clinical Research Powered by PRATIA
Warsaw, Masovian Voivodeship, 02-172
- Recruiting
European Trial group network Sp. z o.o - Neuroscience
Warsaw, Masovian Voivodeship, 02-677
Portugal5 sites, 4 recruiting
- Recruiting
Hospital de Braga
Braga, 4710-367
- Recruiting
Hospital Pediátrico de Coimbra
Coimbra, 3000-602
- Completed
Hospital CUF Descobertas, S.A.
Lisbon, 1998-018
- Recruiting
Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)
Porto, 4050
- Recruiting
Centro Hospitalar Universitario de Sao Joao (CHUSJ)
Porto, 4200-319
Serbia5 sites, 5 recruiting
- Recruiting
Univerzitetska Decija Klinika (UDK) (University Children's Hospital)
Belgrade, Beograd, 11000
- Recruiting
Clinical Center Kragujevac
Kragujevac, Sumadijski Okrug, 34000
- Recruiting
University Clinical Center Nis
Niš, 18 000
- Recruiting
University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic
Novi Sad, Juznobacki Okrug, 21000
- Recruiting
Institute of Child and Youth Health Care of Vojvodina
Novi Sad, Juznobacki Okrug, 21101
Canada4 sites, 3 recruiting
- Recruiting
Kids Clinic
Ajax, Ontario, L1Z 0M1
- Recruiting
London Health Sciences Centre (LHSC)
London, Ontario, N6A 5W9
- Completed
The Medical Arts Health Research Group - Penticton
Penticton, British Columbia, V2A 5C8
- Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
Victoria, British Columbia, V8R 1J8
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
Eskişehir, 26480
- Recruiting
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
Istanbul, 34093
- Recruiting
İzmir Şehir Hastanesi
Izmir, 35540
- Recruiting
Mersin Universitesi-Tip Fakultesi
Mersin, 33343
United Kingdom4 sites, 4 recruiting
- Recruiting
NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
Edinburgh, Eastern Scotland, EH16 4TJ
- Recruiting
NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...
Glasgow, South Western Scotland, G51 4TF
- Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA
- Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)
Vigo, Pontevedra, 36312
Mexico2 sites, 1 recruiting
- Completed
Centro de Investigacion Clinica de Morelia, S.C.
Morelia, Michoacán, 58070
- Recruiting
Clinical Research Institute SC-Mexico
Tepetlacolco, 54055
About this study
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
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
- Conditions
- Episodic Migraine
- Being tested
- Eptinezumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
Solution for infusion
PlaceboDrug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab 300 mg | Experimental | Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted). Receives: Drug: Eptinezumab |
| Placebo | Placebo comparator | Participants will receive a single IV infusion of matching placebo to eptinezumab. Receives: Drug: Placebo |
| Eptinezumab 100 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). Receives: Drug: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Secondary outcomes (12)
Response: ≥50% Reduction From Baseline in MMDs
Measured: Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Measured: On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use
Measured: Baseline, Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Measured: Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Measured: Baseline, Weeks 1-12
Change From Baseline in Monthly Hours with Headache
Measured: Baseline, Weeks 1-12
Change From Baseline in Days with Acute Medication
Measured: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Measured: Baseline, Weeks 1-12
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Measured: Baseline, Week 12
Free Eptinezumab Plasma Concentrations
Measured: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Measured: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
Measured: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start8 Jun 2023
- Primary completion6 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, HQ_Medinfo@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897320
- Sponsor's protocol ID
- 19357A
- Other IDs
- 2022-502538-14-00
- Acronym
- PROSPECT-1
- Status last verified
- Oct 2026
- First submitted
- 31 May 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05897320
- Acronym / sponsor ID
- PROSPECT-1 / 19357A
- Conditions
- Episodic Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab 300 mg | Experimental | Drug: EptinezumabParticipants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of matching placebo to eptinezumab. |
| Eptinezumab 100 mg | Experimental | Drug: EptinezumabParticipants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EptinezumabSolution for infusion | Drug | Eptinezumab 100 mg, Eptinezumab 300 mg |
| PlaceboSolution for infusion | Drug | Placebo |
Primary outcome
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
12 secondary outcomes
Response: ≥50% Reduction From Baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Time frame: On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use
Time frame: Baseline, Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time frame: Baseline, Weeks 1-12
Change From Baseline in Monthly Hours with Headache
Time frame: Baseline, Weeks 1-12
Change From Baseline in Days with Acute Medication
Time frame: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Time frame: Baseline, Weeks 1-12
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time frame: Baseline, Week 12
Free Eptinezumab Plasma Concentrations
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Email contact via H. Lundbeck A/S study director
HQ_Medinfo@Lundbeck.com
60 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptinezumab in people with Episodic Migraine, run by H. Lundbeck A/S at 60 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Argentina, Italy, Poland, Portugal and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 (time frame: Baseline, Weeks 1-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.