Clinical trial • Phase III • Neurology
Eptinezumab for Migraine | Chronic migraine | Episodic migraine
Phase III trial of Eptinezumab for Migraine | Chronic migraine | Episodic migraine.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Migraine | Chronic migraine | Episodic migraine
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 04-03-2024
- First CTIS Authorization Date
- 05-04-2024
Trial design
Randomised, open-label, no external comparator; two experimental arms: eptinezumab 300 mg iv infusions at weeks 0, 12, and 24 and eptinezumab 100 mg iv infusions at weeks 0, 12, and 24.-controlled Phase III trial in Italy, Portugal, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- No external comparator; two experimental arms: Eptinezumab 300 mg IV infusions at Weeks 0, 12, and 24 and Eptinezumab 100 mg IV infusions at Weeks 0, 12, and 24.
- Target Sample Size
- 458
- Trial Duration For Participant
- 252
Eligibility
Recruits 458 paediatric patients.
- Vulnerable Population
- Children and adolescents aged 6 to 17 are included (vulnerable population). Age-specific assent and consent procedures are used: assent forms and paediatric information sheets are provided for age bands (e.g. 6-9, 10-13, 12-17/13-17, 14-17) and parent/guardian consent (Parent-ICF/Main-ICF) is required. Documents are available in country-specific languages (Italian, Portuguese, Polish, Spanish) as per submitted ICF/assent documents.
Inclusion criteria
- {"criterion_text":"- The patient must have completed Week 12 (completion) Visit of either Study 19356A (CM) or Study 19357A (EM) immediately prior to enrolment into this OLE study."}
Exclusion criteria
- {"criterion_text":"- The patient has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator."}
- {"criterion_text":"- During lead-in Study19356A or Study19357A: - participant experienced anaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator. - the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later. - the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Participants With Treatment Emergent Adverse Events","definition_or_measurement_approach":"Not specified in CTIS record"}
Secondary endpoints
- {"endpoint_text":"- Free Eptinezumab Plasma Concentration","definition_or_measurement_approach":"Not specified in CTIS record"}
- {"endpoint_text":"- Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])","definition_or_measurement_approach":"Not specified in CTIS record"}
- {"endpoint_text":"- Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)","definition_or_measurement_approach":"Not specified in CTIS record"}
- {"endpoint_text":"- Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36","definition_or_measurement_approach":"Change from baseline in PedMIDAS score measured at Weeks 12, 24 and 36"}
Recruitment
- Planned Sample Size
- 458
- Recruitment Window Months
- 51
- Consent Approach
- Parent/legal guardian provides informed consent; children provide assent using age-appropriate assent forms. Subject information and consent/assent documents are available in country-specific languages (Italian, Portuguese, Polish, Spanish) and include Main ICF, Parent/Guardian ICF, age-banded assent forms (e.g. 6-9, 10-13, 12-17/13-17, 14-17) and newborn/pregnancy follow-up consent where applicable.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 276
Italy
- Earliest CTIS Part Ii Submission Date
- 19-03-2024
- Latest Decision Or Authorization Date
- 09-09-2025
- Processing Time Days
- 539
- Number Of Sites
- 8
- Number Of Participants
- 51
Sites
- Site Name
- Azienda Socio Sanitaria Locale N. 8 Di Cagliari
- Department Name
- Neurologist
- Contact Person Name
- Maria Giuseppa Ledda
- Contact Person Email
- mariagiuseppinaledda@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Neurologist
- Contact Person Name
- Alice Bonuccelli
- Contact Person Email
- al.bonuccelli@ao-pisa.toscana.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurologist
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- Neurologist
- Contact Person Name
- Renzo Guerrini
- Contact Person Email
- renzo.guerrini@meyer.it
- Site Name
- Giannina Gaslini Institute For Scientific Hospitalization And Care
- Department Name
- Neurologist
- Contact Person Name
- Edoardo Canale
- Contact Person Email
- edoardocanale@gaslini.org
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- Neurologist
- Contact Person Name
- Laura Papetti
- Contact Person Email
- laura.papetti@opbg.net
- Site Name
- Neurological Institute Foundation Casimiro Mondino
- Department Name
- Neurology
- Contact Person Name
- Valentina De Giorgis
- Contact Person Email
- valentina.degiorgis@mondino.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Neurologist
- Contact Person Name
- Licia Grazzi
- Contact Person Email
- licia.grazzi@istituto-besta.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-03-2024
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 538
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Pediatria
- Contact Person Name
- José Ferreira
- Contact Person Email
- jose.ferreira@cuf.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Pediatria - Neuropediatria
- Contact Person Name
- Inês Carrilho
- Contact Person Email
- icarrilho.dia@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Neuropediatria
- Contact Person Name
- Filipe Palavra
- Contact Person Email
- filipepalavra@gmail.com
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Departamento de Pediatria
- Contact Person Name
- Mafalda Sampaio
- Contact Person Email
- mafalda.sampaio@chsj.min-saude.pt
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Pediatria
- Contact Person Name
- João Carvalho
- Contact Person Email
- joao.nuno.carvalho@hgo.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Pediatria
- Contact Person Name
- Susana Carvalho
- Contact Person Email
- susana.carvalho@hb.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 19-03-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 787
- Number Of Sites
- 5
- Number Of Participants
- 51
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Pediatrics
- Contact Person Name
- Eva Arias Vivas
- Contact Person Email
- eva.arias.vivas@gmail.com
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Pediatrics
- Contact Person Name
- Manuel Oscar Blanco Barca
- Contact Person Email
- droblanco@hotmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Headache Unit
- Contact Person Name
- Samuel Díaz Insa
- Contact Person Email
- sdiazinsa@yahoo.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Contact Person Name
- Patricia Pozo-Rosich
- Contact Person Email
- ppozorosich@yahoo.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology Department
- Contact Person Name
- Carmen Gonzalez Oria
- Contact Person Email
- carmengoria@hotmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 04-03-2025
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 192
- Number Of Sites
- 7
- Number Of Participants
- 134
Sites
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Contact Person Name
- Marta Żołnowska
- Contact Person Email
- trials@plejady.com.pl
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- m.boczarska@instytutboczarska.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Contact Person Name
- Damian Okruciński
- Contact Person Email
- badacz@pratia.com
- Site Name
- Etg Neuroscience Sp. z o.o.
- Contact Person Name
- Aleksandra Karbowniczek
- Contact Person Email
- a.karbowniczek@neuroscience.com.pl
- Site Name
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
- Contact Person Name
- Anna Gryglas-Dworak
- Contact Person Email
- anna.gryglas@gmail.com
- Site Name
- Athleticomed Sp. z o.o.
- Contact Person Name
- Magdalena Nowaczewska
- Contact Person Email
- m.nowaczewska@athleticomed.pl
- Site Name
- ETG Lublin Sp. z o.o.
- Department Name
- ETG Lublin Poradnie Specjalistyczne
- Contact Person Name
- Dominika Tomaka
- Contact Person Email
- d.tomaka@etg-network.com
Sponsor
Primary sponsor
- Full Name
- H. Lundbeck A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Clario
- Responsibilities
- Cardiac Services, eCOA
- Name
- Scout Clinical
- Responsibilities
- Patient transportation and patient reimbursement
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Supplies for sample collection and testing of safety labs
- Name
- Medidata Solutions Inc.
- Responsibilities
- Code: 7
- Name
- PPD Development LP
- Responsibilities
- Code: 10
- Name
- PPD International Holdings LLC
- Responsibilities
- Supplies for sample collection and testing of safety labs
Third parties
- {"country":"Switzerland","full_name":"Clario","duties_or_roles":"Cardiac Services, eCOA","organisation_type":"Industry"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient transportation and patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Supplies for sample collection and testing of safety labs","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Code: 10","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Supplies for sample collection and testing of safety labs","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- VYEPTI 100 mg concentrate for solution for infusion
- Active Substance
- Eptinezumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation (EU) - EU/1/21/1599/001
- Starting Dose
- 100 mg or 300 mg (weight adjusted depending on prior assignment)
- Dose Levels
- 100 mg; 300 mg
- Frequency
- Infusions at Weeks 0, 12, and 24
- Maximum Dose
- 300 mg
- Dose Escalation Increase
- 100 mg and 300 mg
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