Clinical trial • Phase III • Neurology
EPTINEZUMAB for Chronic migraine
Phase III trial of EPTINEZUMAB for Chronic migraine.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Chronic migraine
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 09-08-2024
- First CTIS Authorization Date
- 13-09-2024
Trial design
Randomised, experimental: eptinezumab 300 mg iv single infusion (weight adjusted); experimental: eptinezumab 100 mg iv single infusion (weight adjusted); placebo comparator: nacl 0.9% matching to eptinezumab, single iv infusion.-controlled Phase III trial in Portugal, Poland, Italy and others.
- Randomised
- Yes
- Comparator
- Experimental: Eptinezumab 300 mg IV single infusion (weight adjusted); Experimental: Eptinezumab 100 mg IV single infusion (weight adjusted); Placebo comparator: NaCl 0.9% matching to eptinezumab, single IV infusion.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 165
- Trial Duration For Participant
- 84
Eligibility
Recruits 165 paediatric patients.
- Vulnerable Population
- Vulnerable population: adolescents aged 12-17 are included. Consent/assent handling: parent/legal guardian informed consent is required and documented (Parent/Guardian ICF, Parent_Legal-Rep ICF), and age‑appropriate pediatric assent documents are used (Pediatric Assent 12-15; Assent 12-17 / Assent 13-17 as available). There are also subject information and ICF documents for adult patients (Main ICF / Patient 18 years) and newborn/pregnancy follow-up forms. Materials are provided in multiple languages (Portuguese, Polish, Italian, Spanish, English as per available ICF/assent documents).
Inclusion criteria
- {"criterion_text":"- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit."}
- {"criterion_text":"- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit."}
- {"criterion_text":"- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary."}
Exclusion criteria
- {"criterion_text":"- The participant has previously been randomised in this study and exposed to eptinezumab."}
- {"criterion_text":"- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit."}
- {"criterion_text":"- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit."}
- {"criterion_text":"- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- \"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 \"","definition_or_measurement_approach":"Change from baseline in monthly migraine days averaged over Weeks 1-12 as recorded by the participant eDiary (MMDs averaged over Weeks 1-12)."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction from baseline in monthly migraine days averaged over Weeks 1-12 (based on eDiary-recorded MMDs)."}
- {"endpoint_text":"- Percentage of Participants With Migraine on the Day After Dosing (Day 1)","definition_or_measurement_approach":"Proportion of participants with migraine on the day after dosing (Day 1) as recorded in the eDiary."}
- {"endpoint_text":"- Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12","definition_or_measurement_approach":"Change from baseline in monthly migraine days with use of acute medication averaged over Weeks 1-12 (eDiary-recorded)."}
- {"endpoint_text":"- Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12","definition_or_measurement_approach":"Proportion of participants achieving ≥75% reduction from baseline in monthly migraine days averaged over Weeks 1-12 (eDiary)."}
- {"endpoint_text":"- Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4","definition_or_measurement_approach":"Proportion of participants achieving ≥75% reduction from baseline in monthly migraine days averaged over Weeks 1-4 (eDiary)."}
- {"endpoint_text":"- Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction from baseline in monthly migraine days averaged over Weeks 1-4 (eDiary)."}
- {"endpoint_text":"- Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12","definition_or_measurement_approach":"Change from baseline in monthly headache days averaged over Weeks 1-12 (eDiary-recorded headache days)."}
- {"endpoint_text":"- Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12","definition_or_measurement_approach":"Change from baseline in rate of migraines with severe pain intensity averaged over Weeks 1-12 (severity recorded in eDiary)."}
- {"endpoint_text":"- Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12","definition_or_measurement_approach":"Change from baseline in days with use of acute medication averaged over Weeks 1-12 (eDiary-recorded medication use)."}
- {"endpoint_text":"- Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12","definition_or_measurement_approach":"Change from baseline in PedMIDAS score averaged over Weeks 1-12 (questionnaire-based assessment)."}
- {"endpoint_text":"- Free Eptinezumab Plasma Concentration","definition_or_measurement_approach":"Measurement of free eptinezumab plasma concentration (pharmacokinetic assay)."}
- {"endpoint_text":"- Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])","definition_or_measurement_approach":"Number of participants with specific anti-eptinezumab antibodies detected by ADA assays."}
- {"endpoint_text":"- Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)","definition_or_measurement_approach":"Number of participants with anti-eptinezumab antibodies displaying neutralizing activity (NAb assays)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 165
- Recruitment Window Months
- 52
- Consent Approach
- Informed consent and assent: parent/legal guardian provides consent for minors (Parent/Guardian ICF / Parent_Legal-Rep ICF) and adolescents provide age-appropriate assent (Pediatric Assent 12-15; Assent 12-17 / Assent 13-17 documents). Adult participants (18 years) sign Main ICF. Additional forms for newborn/pregnancy follow-up and father/newborn ICFs are available. Some pre-consent telephone procedures (Scout Clinical Pre-ICF Telephone Data Consent) are used. Materials and ICF/assent documents are provided in multiple languages (Portuguese, Polish, Italian, Spanish, English where available).
Methods
- Use of recruitment materials (posters) - country-specific recruitment posters available (document titles: Recruitment-Poster for PT/PL/IT/ES).
- GP letters and referral letters - GP-Letter and Referral-Letter documents present for multiple countries.
- Website materials - country-specific study websites and 'Website' documents (PT/IT/ES) used as recruitment channel.
- Educational videos and links - 'Link-for-videos' and 'Link-for-update-video' materials referenced in recruitment documents.
- IA flipcharts and local awareness materials (IA-Flip-Chart) used at sites.
- Patient-facing explanatory materials ('Understanding-Eptinezumab' for adolescents/adults) in multiple languages.
- Pre-ICF telephone consent/data collection by Scout Clinical (Scout Clinical Pre-ICF Telephone Data Consent).
- Patient transportation and reimbursement support (Scout Clinical duties) and site-level recruitment/retention services (Jumo Health duties).
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 174
Portugal
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 168
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Departamento de Pediatria
- Principal Investigator Name
- Mafalda Sampaio
- Principal Investigator Email
- mafalda.sampaio@chsj.min-saude.pt
- 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
- Principal Investigator Name
- João Carvalho
- Principal Investigator Email
- joao.nuno.carvalho@hgo.min-saude.pt
- Contact Person Name
- João Carvalho
- Contact Person Email
- joao.nuno.carvalho@hgo.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Neuropediatria
- Principal Investigator Name
- Filipe Palavra
- Principal Investigator Email
- filipepalavra@gmail.com
- Contact Person Name
- Filipe Palavra
- Contact Person Email
- filipepalavra@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 17-09-2025
- Processing Time Days
- 181
- Number Of Sites
- 7
- Number Of Participants
- 44
Sites
- Site Name
- ETG Lublin Sp. z o.o.
- Department Name
- ETG Lublin Poradnie Specjalistyczne
- Principal Investigator Name
- Dominika Tomaka
- Principal Investigator Email
- d.tomaka@etg-network.com
- Contact Person Name
- Dominika Tomaka
- Contact Person Email
- d.tomaka@etg-network.com
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Principal Investigator Name
- Marta Żołnowska
- Principal Investigator Email
- trials@plejady.com.pl
- 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.
- Principal Investigator Name
- Magdalena Boczarska-Jedynak
- Principal Investigator Email
- m.boczarska@instytutboczarska.pl
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- m.boczarska@instytutboczarska.pl
- Site Name
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
- Principal Investigator Name
- Anna Gryglas-Dworak
- Principal Investigator Email
- anna.gryglas@migre.pl
- Contact Person Name
- Anna Gryglas-Dworak
- Contact Person Email
- anna.gryglas@migre.pl
- Site Name
- Athleticomed Sp. z o.o.
- Principal Investigator Name
- Magdalena Nowaczewska
- Principal Investigator Email
- m.nowaczewska@athleticomed.pl
- Contact Person Name
- Magdalena Nowaczewska
- Contact Person Email
- m.nowaczewska@athleticomed.pl
- Site Name
- Etg Neuroscience Sp. z o.o.
- Principal Investigator Name
- Aleksandra Karbowniczek
- Principal Investigator Email
- a.karbowniczek@neuroscience.com.pl
- Contact Person Name
- Aleksandra Karbowniczek
- Contact Person Email
- a.karbowniczek@neuroscience.com.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Damian Okruciński
- Principal Investigator Email
- badacz@pratia.com
- Contact Person Name
- Damian Okruciński
- Contact Person Email
- badacz@pratia.com
Italy
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 418
- Number Of Sites
- 7
- Number Of Participants
- 60
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- Neurologist
- Principal Investigator Name
- Laura Papetti
- Principal Investigator Email
- laura.papetti@opbg.net
- Contact Person Name
- Laura Papetti
- Contact Person Email
- laura.papetti@opbg.net
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- Neurologist
- Principal Investigator Name
- Edoardo Canale
- Principal Investigator Email
- edoardocanale@gaslini.org
- Contact Person Name
- Edoardo Canale
- Contact Person Email
- edoardocanale@gaslini.org
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Neurologist
- Principal Investigator Name
- Licia Grazzi
- Principal Investigator Email
- licia.grazzi@istituto-besta.it
- Contact Person Name
- Licia Grazzi
- Contact Person Email
- licia.grazzi@istituto-besta.it
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- Neurologist
- Principal Investigator Name
- Renzo Guerrini
- Principal Investigator Email
- renzo.guerrini@meyer.it
- Contact Person Name
- Renzo Guerrini
- Contact Person Email
- renzo.guerrini@meyer.it
- Site Name
- Azienda Socio Sanitaria Locale N. 8 Di Cagliari
- Department Name
- Neurologist
- Principal Investigator Name
- Maria Giuseppa Ledda
- Principal Investigator Email
- mariagiuseppinaledda@gmail.com
- Contact Person Name
- Maria Giuseppa Ledda
- Contact Person Email
- mariagiuseppinaledda@gmail.com
- Site Name
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino
- Department Name
- Neurologist
- Principal Investigator Name
- Valentina De Giorgis
- Principal Investigator Email
- valentina.degiorgis@mondino.it
- Contact Person Name
- Valentina De Giorgis
- Contact Person Email
- valentina.degiorgis@mondino.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurologist
- Principal Investigator Name
- Massimo Filippi
- Principal Investigator Email
- filippi.massimo@hsr.it
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 624
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Headache Unit
- Principal Investigator Name
- Samuel Díaz Insa
- Principal Investigator Email
- sdiazinsa@yahoo.es
- Contact Person Name
- Samuel Díaz Insa
- Contact Person Email
- sdiazinsa@yahoo.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Pediatrics
- Principal Investigator Name
- Eva Arias Vivas
- Principal Investigator Email
- eva.arias.vivas@gmail.com
- Contact Person Name
- Eva Arias Vivas
- Contact Person Email
- eva.arias.vivas@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Patricia Pozo-Rosich
- Principal Investigator Email
- patricia.pozo@vhir.org
- Contact Person Name
- Patricia Pozo-Rosich
- Contact Person Email
- patricia.pozo@vhir.org
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Pediatrics
- Principal Investigator Name
- Manuel Oscar Blanco Barca
- Principal Investigator Email
- droblanco@hotmail.com
- Contact Person Name
- Manuel Oscar Blanco Barca
- Contact Person Email
- droblanco@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology Department
- Principal Investigator Name
- Carmen Gonzalez Oria
- Principal Investigator Email
- carmengoria@hotmail.com
- Contact Person Name
- Carmen Gonzalez Oria
- Contact Person Email
- carmengoria@hotmail.com
Sponsor
Primary sponsor
- Full Name
- H. Lundbeck A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- PPD International Holdings LLC
- Responsibilities
- Supplies for sample collection and testing of safety labs
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Supplies for sample collection and testing of safety labs
- Name
- PPD Development LP
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Cardiac Services, eCOA
- Name
- Medidata Solutions Inc.
Third parties
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient recruitment and retention materials","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient transportation and patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Belgium","full_name":"PPD International Holdings 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":"","organisation_type":"Non-Pharmaceutical company"}
- {"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":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Services, eCOA","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 USE
- Route
- Intravenous
- Authorisation Status
- Authorised (EU MA: EU/1/21/1599/001)
- Starting Dose
- 100 mg (one of the study doses; weight adjusted)
- Dose Levels
- 100 mg; 300 mg
- Frequency
- Single IV infusion
- Maximum Dose
- 300 mg
- Investigational Product Name
- Nacl 0.9%
- Modality
- Other
- Routes Of Administration
- Intravenous (placebo matching eptinezumab)
- Route
- Intravenous
- Authorisation Status
- Not authorised / N/A
- Starting Dose
- Placebo matching single IV infusion
- Frequency
- Single IV infusion
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