Clinical trial • Phase II • Neurology
LU AG09222 for Migraine
Phase II trial of LU AG09222 for Migraine.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Migraine
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-03-2024
- First CTIS Authorization Date
- 22-07-2024
Trial design
Randomised, placebo to match imp lu ag09222 administered on the same schedule as active (subcutaneous dosing at baseline, week 4 and week 8; participants receive 3 doses over the initial 8 weeks).-controlled Phase II trial in Lithuania, Germany, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Placebo to match IMP Lu AG09222 administered on the same schedule as active (subcutaneous dosing at baseline, Week 4 and Week 8; participants receive 3 doses over the initial 8 weeks).
- Target Sample Size
- 484
- Trial Duration For Participant
- 140
Eligibility
Recruits 484 adults.
Inclusion criteria
- {"criterion_text":"- The participant has a diagnosis of migraine as defined by ICHD-3 guidelines (section 1.1 Migraine without Aura, or 1.2.1 Migraine with typical Aura, or 1.3 Chronic Migraine) confirmed at the Screening Visit."}
- {"criterion_text":"- The participant has a history of migraine onset ≥12 months prior to the Screening Visit."}
- {"criterion_text":"- The participant has a migraine onset at ≤50 years of age."}
- {"criterion_text":"- The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit."}
- {"criterion_text":"- The participant fulfils the following criteria for EM or CM in prospectively collected information in the eDiary during the first 28 days of the Screening Period: o\tFor participants with EM: migraine occurring on ≥4 days and headache occurring on <15 days o\tFor participants with CM: migraine occurring on ≥8 days and headache occurring on ≥15 days and ≤26 days"}
- {"criterion_text":"- The participant has demonstrated compliance with the eDiary by entry of data for ≥24 of the 28 days following the Screening Visit."}
- {"criterion_text":"- The participant has had treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications out of the following, of which at least one must be due to inadequate efficacy: o\tpropranolol/metoprolol o\ttopiramate o\tamitriptyline o\tflunarizine/lomerizine o\tcandesartan o\tvalproate/divalproex o\tbotulinum toxin (if documented that botulinum toxin was taken for CM)"}
- {"criterion_text":"- The participant is aged ≥18 and ≤65 years at the Screening Visit"}
Exclusion criteria
- {"criterion_text":"- The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome)."}
- {"criterion_text":"- The participant has a diagnosis of acute or active temporomandibular disorder."}
- {"criterion_text":"- The participant has a history or diagnosis of chronic tension-type headache, cluster headache, headache attributed to trauma or injury to the head and/or neck, paroxysmal hemicrania, short lasting unilateral neuralgiform headache attacks, hemicrania continua, primary thunderclap headache, primary stabbing headache, nummular headache, new daily persistent headache, hypnic headache, trigeminal neuralgia, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness) or aura lasting >60 minutes."}
- {"criterion_text":"- The following concomitant medications/substances are disallowed or allowed with restrictions (the list is not comprehensive): Disallowed: any investigational products within 30 days or 5 half-lives (whichever is longer) before the Screening Visit; preventive migraine treatments; anti-CGRP treatment; CNS- or migraine-related devices (neuromodulation, neurostimulation) or injectable therapies (such as trigger-point injections, extracranial nerve blocks, or facet joint injections); botulinum toxin; or monoamine oxidase inhibitors, ketamine, methysergide, methylergonovine, or nimesulide; immunosuppressants (for example, systemic steroids). Allowed with restriction: acute treatment of migraine (prescription or OTC medication), amphetamines, anti-impotence agents; barbiturates (including Fiorinal, Fioricet, or any other combination containing butalbital); opiates (including single-ingredient or combination medications containing opiates, opioids, tramadol, or tapentadol); cannabinoids; benzodiazepines; inhalation steroids; vaccinations; nonpharmacological interventions and therapies; traditional Chinese medicines."}
- {"criterion_text":"- The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in Monthly Migraine Diary (Weeks 1-12) (efficacy)","definition_or_measurement_approach":"Change from baseline measured using the Monthly Migraine Diary collected prospectively (eDiary) during Weeks 1-12; assessed as difference from baseline diary entries."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in Monthly Migraine Diary (Weeks 1-12) (dose response)","definition_or_measurement_approach":"Change from baseline in the Monthly Migraine Diary (Weeks 1-12) analysed for dose-response relationship using diary (eDiary) entries."}
- {"endpoint_text":"- Change from baseline in Monthly Migraine Diary (Weeks 1-12) (dose response)","definition_or_measurement_approach":"Change from baseline in Monthly Migraine Diary (Weeks 1-12) analysed by dose group using prospectively collected eDiary data."}
- {"endpoint_text":"- 50% Monthly Migraine Diary response: ≥50% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12)","definition_or_measurement_approach":"Responder analysis defined as ≥50% reduction from baseline in Monthly Migraine Diary entries over Weeks 1-12."}
- {"endpoint_text":"- 75% Monthly Migraine Diary response: ≥75% reduction from baseline in Monthly Migraine Diaries (Weeks 1-12)","definition_or_measurement_approach":"Responder analysis defined as ≥75% reduction from baseline in Monthly Migraine Diary entries over Weeks 1-12."}
- {"endpoint_text":"- Change from baseline in Monthly Headache Days (Weeks 1-12)","definition_or_measurement_approach":"Change from baseline in number of monthly headache days measured via Monthly Migraine/Headache Diary (eDiary) during Weeks 1-12."}
- {"endpoint_text":"- TEAEs","definition_or_measurement_approach":"Treatment-emergent adverse events collected and reported per standard safety reporting (TEAEs)."}
- {"endpoint_text":"- Changes from baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values","definition_or_measurement_approach":"Laboratory values, vital signs, weight and ECG parameters measured at scheduled visits and compared to baseline; standard clinical safety laboratory assessments."}
- {"endpoint_text":"- PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values","definition_or_measurement_approach":"Potentially clinically significant (PCS) changes in safety laboratory tests, vital signs, weight and ECG parameters identified per predefined criteria."}
- {"endpoint_text":"- Suicidal ideation and behaviour based on the C-SSRS","definition_or_measurement_approach":"Assessment of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS) at scheduled timepoints."}
- {"endpoint_text":"- Development of ADAs, characterization of ADAs, and impact of ADA on PK, efficacy, and safety","definition_or_measurement_approach":"Immunogenicity assessed by anti-drug antibody (ADA) assays; characterization of ADA and its impact on pharmacokinetics (PK), efficacy and safety analyzed."}
Recruitment
- Digital Remote Recruitment
- True - digital/remote methods include online postings, website prescreener and digital outreach materials as indicated by documents named 'K2_Migraine_Participant Recruit Digital Outreach' and 'K2_Online Posting'.
- Planned Sample Size
- 484
- Recruitment Window Months
- 22
- Consent Approach
- Written informed consent obtained from each participant (participants are adults aged ≥18 and ≤65; no assent). Country- and language-specific ICFs are provided (documents include ICFs in multiple languages / country-specific versions such as English, German, French, Spanish, Polish, Hungarian, Romanian, Czech, Slovak, Lithuanian, Bulgarian and others as per country sites).
Methods
- Digital/online outreach: documents titled 'K2_Online Posting', 'K2_Migraine_Participant Recruit Digital Outreach', 'K2_Website Copy with Prescreener' indicate use of online postings and a website prescreener targeted to people with migraine.
- Printed and site materials: Flyers, Posters and Patient Letters ('K2_Flyer', 'K2_Poster', 'K2_Patient Letter') to be distributed at sites and clinics.
- Site-based recruitment: recruitment through participating neurology / headache clinics and hospital centres (site lists provided per country).
Geography
- Total Number Of Sites
- 79
- Total Number Of Participants
- 552
Lithuania
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 39
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Neurology center
- Principal Investigator Name
- Dalius Jatuzis
- Principal Investigator Email
- dalius.jatuzis@santa.lt
- Contact Person Name
- Dalius Jatuzis
- Contact Person Email
- dalius.jatuzis@santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Neurology department
- Principal Investigator Name
- Diana Obelieniene
- Principal Investigator Email
- diana.obelieniene@kaunoklinikos.lt
- Contact Person Name
- Diana Obelieniene
- Contact Person Email
- diana.obelieniene@kaunoklinikos.lt
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- Neurology center
- Principal Investigator Name
- Lina Malciene
- Principal Investigator Email
- lina.malciene@kulig.lt
- Contact Person Name
- Lina Malciene
- Contact Person Email
- lina.malciene@kulig.lt
- Site Name
- Medicum Centrum UAB
- Principal Investigator Name
- Ovidijus Laucius
- Principal Investigator Email
- ovidijus.laucius@kaunoklinikos.lt
- Contact Person Name
- Ovidijus Laucius
- Contact Person Email
- ovidijus.laucius@kaunoklinikos.lt
Germany
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 8
- Number Of Participants
- 61
Sites
- Site Name
- Kopfschmerzzentrum Frankfurt
- Principal Investigator Name
- Charly Gaul
- Principal Investigator Email
- info@kopfschmerz-frankfurt.de
- Contact Person Name
- Charly Gaul
- Contact Person Email
- info@kopfschmerz-frankfurt.de
- Site Name
- Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
- Principal Investigator Name
- Hartmut Goebel
- Principal Investigator Email
- heinze@schmerzklinik.de
- Contact Person Name
- Hartmut Goebel
- Contact Person Email
- heinze@schmerzklinik.de
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Klinik und Poliklinik für Neurologie
- Principal Investigator Name
- Robert Fleischmann
- Principal Investigator Email
- robert.fleischmann@med.uni-greifswald.de
- Contact Person Name
- Robert Fleischmann
- Contact Person Email
- robert.fleischmann@med.uni-greifswald.de
- Site Name
- Siteworks GmbH (Heidelberg)
- Principal Investigator Name
- Niels-Christian Hoellger
- Principal Investigator Email
- info@siteworks-research.de
- Contact Person Name
- Niels-Christian Hoellger
- Contact Person Email
- info@siteworks-research.de
- Site Name
- Siteworks GmbH (Hanover)
- Principal Investigator Name
- Ulrike Lengler
- Principal Investigator Email
- info@siteworks-research.de
- Contact Person Name
- Ulrike Lengler
- Contact Person Email
- info@siteworks-research.de
- Site Name
- Studienzentrum Dr. Bischof GmbH
- Principal Investigator Name
- Felix Bischof
- Principal Investigator Email
- felix.bischof@me.com
- Contact Person Name
- Felix Bischof
- Contact Person Email
- felix.bischof@me.com
- Site Name
- curiositas ad sanum Studien und Beratungs GmbH
- Principal Investigator Name
- Johannes Schwarz
- Principal Investigator Email
- s.schwarz@curiositas-ad-sanum.de
- Contact Person Name
- Johannes Schwarz
- Contact Person Email
- s.schwarz@curiositas-ad-sanum.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Neurology
- Principal Investigator Name
- Bianca Raffaelli
- Principal Investigator Email
- kopfschmerz@charite.de
- Contact Person Name
- Bianca Raffaelli
- Contact Person Email
- kopfschmerz@charite.de
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 42
Sites
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- Neurology
- Principal Investigator Name
- Krasimir Genov
- Principal Investigator Email
- jeliazko@convex.bg
- Contact Person Name
- Krasimir Genov
- Contact Person Email
- jeliazko@convex.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Neurology
- Principal Investigator Name
- Penka Atanasova
- Principal Investigator Email
- hristiyan.kosturski@clineca.net
- Contact Person Name
- Penka Atanasova
- Contact Person Email
- hristiyan.kosturski@clineca.net
- Site Name
- Medical Center Rusemed EOOD
- Department Name
- Neurology
- Principal Investigator Name
- Aleksandar Bosilkov
- Principal Investigator Email
- rusemed@gmail.com
- Contact Person Name
- Aleksandar Bosilkov
- Contact Person Email
- rusemed@gmail.com
- Site Name
- Medical Center Nevrocentrum EOOD
- Department Name
- Neurology
- Principal Investigator Name
- Radoslav Mavrov
- Principal Investigator Email
- vaniamav@abv.bg
- Contact Person Name
- Radoslav Mavrov
- Contact Person Email
- vaniamav@abv.bg
- Site Name
- Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
- Department Name
- Neurology
- Principal Investigator Name
- Dimitar Maslarov
- Principal Investigator Email
- maslarovdb@abv.bg
- Contact Person Name
- Dimitar Maslarov
- Contact Person Email
- maslarovdb@abv.bg
- Site Name
- Diagnostic And Consultative Center Neoclinic EAD
- Department Name
- Neurology
- Principal Investigator Name
- Rosen Ikonomov
- Principal Investigator Email
- aivanova@neoclinic.bg
- Contact Person Name
- Rosen Ikonomov
- Contact Person Email
- aivanova@neoclinic.bg
Poland
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 19
- Number Of Participants
- 132
Sites
- Site Name
- Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
- Principal Investigator Name
- Magdalena Boczarska-Jedynak
- Principal Investigator Email
- info@instytutboczarska.pl
- Contact Person Name
- Magdalena Boczarska-Jedynak
- Contact Person Email
- info@instytutboczarska.pl
- Site Name
- Clinirem Sp. z o.o.
- Principal Investigator Name
- Urszula Chyrchel-Paszkiewicz
- Principal Investigator Email
- ullach@poczta.onet.pl
- Contact Person Name
- Urszula Chyrchel-Paszkiewicz
- Contact Person Email
- ullach@poczta.onet.pl
- Site Name
- Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
- Principal Investigator Name
- Maria Fortak-Michalska
- Principal Investigator Email
- mfortak@op.pl
- Contact Person Name
- Maria Fortak-Michalska
- Contact Person Email
- mfortak@op.pl
- Site Name
- Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
- Principal Investigator Name
- Justyna Hryniewicz
- Principal Investigator Email
- hhmscentrum@gmail.com
- Contact Person Name
- Justyna Hryniewicz
- Contact Person Email
- hhmscentrum@gmail.com
- Site Name
- Centrum Medyczne Hope Clinic Sebastian Szklener
- Principal Investigator Name
- Sebastian Szklener
- Principal Investigator Email
- sebastianszklener@gmail.com
- Contact Person Name
- Sebastian Szklener
- Contact Person Email
- sebastianszklener@gmail.com
- Site Name
- Rcmed Oddzial Sochaczew
- Principal Investigator Name
- Malgorzata Fengler-Czeczko
- Principal Investigator Email
- rcmed@rcmed.com.pl
- Contact Person Name
- Malgorzata Fengler-Czeczko
- Contact Person Email
- rcmed@rcmed.com.pl
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Agata Kłósek
- Principal Investigator Email
- klosek@twojaprzychodnia.com
- Contact Person Name
- Agata Kłósek
- Contact Person Email
- klosek@twojaprzychodnia.com
- Site Name
- Centrum Medyczne Neuroprotect
- Principal Investigator Name
- Maciej Czarnecki
- Principal Investigator Email
- maciej.czarnecki@neuroprotect.pl
- Contact Person Name
- Maciej Czarnecki
- Contact Person Email
- maciej.czarnecki@neuroprotect.pl
- Site Name
- Clinhouse Sp. z o.o.
- Department Name
- ClinHouse Centrum Medyczne
- Principal Investigator Name
- Klaudiusz Kumor
- Principal Investigator Email
- jakub.knysak@cmclinhouse.pl
- Contact Person Name
- Klaudiusz Kumor
- Contact Person Email
- jakub.knysak@cmclinhouse.pl
- Site Name
- Appletreeclinics Network Sp. z o.o.
- Principal Investigator Name
- Witold Neuman
- Principal Investigator Email
- sekretariat@appletree.com.pl
- Contact Person Name
- Witold Neuman
- Contact Person Email
- sekretariat@appletree.com.pl
- Site Name
- Pratia S.A. (Cracow)
- Department Name
- Pratia MCM Kraków
- Principal Investigator Name
- Katarzyna Kasprzyk
- Principal Investigator Email
- kkasprzyk-galon@pratia.pl
- Contact Person Name
- Katarzyna Kasprzyk
- Contact Person Email
- kkasprzyk-galon@pratia.pl
- Site Name
- Centrum Medyczne Hcp Sp. z o.o.
- Principal Investigator Name
- Przemysław Osip
- Principal Investigator Email
- monika.stanley@cmhcp.pl
- Contact Person Name
- Przemysław Osip
- Contact Person Email
- monika.stanley@cmhcp.pl
- Site Name
- Neuro-Care Sp. z o.o. sp.k.
- Principal Investigator Name
- Gabriela Kłodowska
- Principal Investigator Email
- neuro-care@neuro-care.pl
- Contact Person Name
- Gabriela Kłodowska
- Contact Person Email
- neuro-care@neuro-care.pl
- Site Name
- Pratia S.A. (Bydgoszcz)
- Department Name
- Centrum Medyczne Pratia Bydgoszcz
- Principal Investigator Name
- Józef Kościelniak
- Principal Investigator Email
- jozef.koscielniak@pratia.pl
- Contact Person Name
- Józef Kościelniak
- Contact Person Email
- jozef.koscielniak@pratia.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Krystyna Gospodarczyk-Szot
- Principal Investigator Email
- krysiaszot@wp.pl
- Contact Person Name
- Krystyna Gospodarczyk-Szot
- Contact Person Email
- krysiaszot@wp.pl
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Principal Investigator Name
- Jolanta Zagórska
- Principal Investigator Email
- b.gornikiewicz-brzezicka@ckb.elblag.pl
- Contact Person Name
- Jolanta Zagórska
- Contact Person Email
- b.gornikiewicz-brzezicka@ckb.elblag.pl
- Site Name
- Indywidualna Praktyka lekarska Dr. hab. n. med. Anna Szczepańska-Szerej
- Principal Investigator Name
- Anna Szczepańska-Szerej
- Principal Investigator Email
- aszerej@poczta.onet.pl
- Contact Person Name
- Anna Szczepańska-Szerej
- Contact Person Email
- aszerej@poczta.onet.pl
- Site Name
- Specjalistyczne Gabinety Lekarskie Landa
- Principal Investigator Name
- Anna Borratyńska
- Principal Investigator Email
- landa@smo.com.pl
- Contact Person Name
- Anna Borratyńska
- Contact Person Email
- landa@smo.com.pl
- Site Name
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
- Principal Investigator Name
- Anna Gryglas-Dworak
- Principal Investigator Email
- anna.gryglas@gmail.com
- Contact Person Name
- Anna Gryglas-Dworak
- Contact Person Email
- anna.gryglas@gmail.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 6
- Number Of Participants
- 26
Sites
- Site Name
- In Medic s.r.o
- Department Name
- Neurologická ambulancia Sv. Jakuba 8 085 01 Bardejov
- Principal Investigator Name
- Jana Chamilová
- Principal Investigator Email
- inmedic7@gmail.com
- Contact Person Name
- Jana Chamilová
- Contact Person Email
- inmedic7@gmail.com
- Site Name
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
- Department Name
- Neurologická ambulancia Palúčanská 214/25 03101 Liptovský Mikuláš
- Principal Investigator Name
- Michal Kováčik
- Principal Investigator Email
- kovacik@nsplm.sk
- Contact Person Name
- Michal Kováčik
- Contact Person Email
- kovacik@nsplm.sk
- Site Name
- MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
- Department Name
- Neurologická ambulancia Nová 4410/21 97404 Banská Bystrica
- Principal Investigator Name
- Beata Dupejová
- Principal Investigator Email
- ambulancia.dupejova@gmail.com
- Contact Person Name
- Beata Dupejová
- Contact Person Email
- ambulancia.dupejova@gmail.com
- Site Name
- Konzilium s.r.o.
- Department Name
- Neurologická ambulancia A.Kmeťa 370/15 018 41 Dubnica nad Váhom
- Principal Investigator Name
- Magdalena Perichtová
- Principal Investigator Email
- konzilium.med@gmail.com
- Contact Person Name
- Magdalena Perichtová
- Contact Person Email
- konzilium.med@gmail.com
- Site Name
- Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
- Department Name
- Neurologická ambulancia Satinského 7770/1 811 08 Bratislava
- Principal Investigator Name
- František Jurčaga
- Principal Investigator Email
- frantisek.jurcaga@nsmas.sk
- Contact Person Name
- František Jurčaga
- Contact Person Email
- frantisek.jurcaga@nsmas.sk
- Site Name
- Sanera s.r.o.
- Department Name
- Neurologická ambulancia Jána Hollého 5898/14D 08001 Prešov
- Principal Investigator Name
- Hedviga Jakubíková
- Principal Investigator Email
- hjakub@gmail.com
- Contact Person Name
- Hedviga Jakubíková
- Contact Person Email
- hjakub@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 31
- Number Of Sites
- 11
- Number Of Participants
- 92
Sites
- Site Name
- Neurologie Rs Centrum s.r.o.
- Department Name
- NZZ – Privátní ordinace neurologie
- Principal Investigator Name
- Radomír Taláb
- Principal Investigator Email
- radomir.talab@gmail.com
- Contact Person Name
- Radomír Taláb
- Contact Person Email
- radomir.talab@gmail.com
- Site Name
- INEP medical s.r.o.
- Department Name
- Neurologické oddělení, klinická hodnocení
- Principal Investigator Name
- Tomáš Nežádal
- Principal Investigator Email
- nezadal@gmail.com
- Contact Person Name
- Tomáš Nežádal
- Contact Person Email
- nezadal@gmail.com
- Site Name
- NeuroMed Zlin s.r.o.
- Department Name
- Neurologická ambulance
- Principal Investigator Name
- Monika Záhumenská
- Principal Investigator Email
- zahumenska@seznam.cz
- Contact Person Name
- Monika Záhumenská
- Contact Person Email
- zahumenska@seznam.cz
- Site Name
- Neuros s.r.o.
- Department Name
- Neurologická ambulance
- Principal Investigator Name
- Hana Rosenbergová
- Principal Investigator Email
- roshana@seznam.cz
- Contact Person Name
- Hana Rosenbergová
- Contact Person Email
- roshana@seznam.cz
- Site Name
- Neurosanatio s.r.o.
- Department Name
- Neurologická ambulance
- Principal Investigator Name
- Karel Zinek
- Principal Investigator Email
- karel.zinek@seznam.cz
- Contact Person Name
- Karel Zinek
- Contact Person Email
- karel.zinek@seznam.cz
- Site Name
- Praglandia s.r.o.
- Principal Investigator Name
- Luisa Bärtlová
- Principal Investigator Email
- l.bartl@praglandia.cz
- Contact Person Name
- Luisa Bärtlová
- Contact Person Email
- l.bartl@praglandia.cz
- Site Name
- Dado Medical s.r.o.
- Department Name
- Neurologie, Headache Centrum
- Principal Investigator Name
- David Doležil
- Principal Investigator Email
- research@dadomedical.cz
- Contact Person Name
- David Doležil
- Contact Person Email
- research@dadomedical.cz
- Site Name
- Forbeli s.r.o.
- Department Name
- Neurologická ambulance
- Principal Investigator Name
- Michal Bajaček
- Principal Investigator Email
- mbajacek@yahoo.co.uk
- Contact Person Name
- Michal Bajaček
- Contact Person Email
- mbajacek@yahoo.co.uk
- Site Name
- Clintrial s.r.o.
- Department Name
- Neurologické oddělení
- Principal Investigator Name
- Miroslava Chýlová
- Principal Investigator Email
- m.chylova@clintrial.cz
- Contact Person Name
- Miroslava Chýlová
- Contact Person Email
- m.chylova@clintrial.cz
- Site Name
- Axon Clinical s.r.o.
- Principal Investigator Name
- Zuzana Matoušová
- Principal Investigator Email
- zuzmat62@gmail.com
- Contact Person Name
- Zuzana Matoušová
- Contact Person Email
- zuzmat62@gmail.com
- Site Name
- MP-neuro s.r.o.
- Department Name
- Neurologická ambulance
- Principal Investigator Name
- Danuše Roubcová
- Principal Investigator Email
- danuse.roubcova@gmail.com
- Contact Person Name
- Danuše Roubcová
- Contact Person Email
- danuse.roubcova@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 15-11-2024
- Processing Time Days
- 29
- Number Of Sites
- 9
- Number Of Participants
- 36
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Département de Neurologie
- Principal Investigator Name
- Caroline Roos
- Principal Investigator Email
- caroline.roos@aphp.fr
- Contact Person Name
- Caroline Roos
- Contact Person Email
- caroline.roos@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Département de la douleur
- Principal Investigator Name
- Michel Lanteri-Minet
- Principal Investigator Email
- lanteri-minet.m@chu-nice.fr
- Contact Person Name
- Michel Lanteri-Minet
- Contact Person Email
- lanteri-minet.m@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neurochirurgie
- Principal Investigator Name
- Christian Lucas
- Principal Investigator Email
- christian.lucas@chu-lille.fr
- Contact Person Name
- Christian Lucas
- Contact Person Email
- christian.lucas@chu-lille.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Centre d’Evaluation et de Traitement de la Douleur
- Principal Investigator Name
- Geneviève Demarquay
- Principal Investigator Email
- genevieve.demarquay@chu-lyon.fr
- Contact Person Name
- Geneviève Demarquay
- Contact Person Email
- genevieve.demarquay@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Neurologie
- Principal Investigator Name
- Solène De Gaalon
- Principal Investigator Email
- solene.degaalon@chu-nantes.fr
- Contact Person Name
- Solène De Gaalon
- Contact Person Email
- solene.degaalon@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d’Evaluation et de Traitement de la Douleur
- Principal Investigator Name
- Anne Donnet
- Principal Investigator Email
- anne.donnet@ap-hm.fr
- Contact Person Name
- Anne Donnet
- Contact Person Email
- anne.donnet@ap-hm.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Neurologie
- Principal Investigator Name
- Xavier Moisset
- Principal Investigator Email
- xmoisset@chu-clermontferrand.fr
- Contact Person Name
- Xavier Moisset
- Contact Person Email
- xmoisset@chu-clermontferrand.fr
- Site Name
- CHU Besancon
- Department Name
- Département de Neurologie
- Principal Investigator Name
- Fabrice Vuillier
- Principal Investigator Email
- fabrice.vuillier@univ-fcomte.fr
- Contact Person Name
- Fabrice Vuillier
- Contact Person Email
- fabrice.vuillier@univ-fcomte.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neurologie
- Principal Investigator Name
- Cedric Gollion
- Principal Investigator Email
- gollion.c@chu-toulouse.fr
- Contact Person Name
- Cedric Gollion
- Contact Person Email
- gollion.c@chu-toulouse.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 02-07-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- Rigshospitalet
- Department Name
- Glostrup Hospital Dansk Hovedpinecenter Neurologisk Klinik
- Principal Investigator Name
- Ashina Messoud
- Principal Investigator Email
- Messoud.ashina@regionh.dk
- Contact Person Name
- Ashina Messoud
- Contact Person Email
- Messoud.ashina@regionh.dk
- Site Name
- Copenhagen University Hospital
- Department Name
- Neurologisk Adeling Bispebjerg Hospital
- Principal Investigator Name
- Dorte Phillip
- Principal Investigator Email
- dorte.phillip.01@regionh.dk
- Contact Person Name
- Dorte Phillip
- Contact Person Email
- dorte.phillip.01@regionh.dk
Romania
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 100
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Clubul Sanatatii S.R.L.
- Principal Investigator Name
- Emilian Silviu Manescu
- Principal Investigator Email
- clubul.sanatatii@yahoo.com
- Contact Person Name
- Emilian Silviu Manescu
- Contact Person Email
- clubul.sanatatii@yahoo.com
- Site Name
- Policlinica CCBR S.R.L.
- Principal Investigator Name
- Daniela Bartos
- Principal Investigator Email
- secretariat@clinicaccbr.com
- Contact Person Name
- Daniela Bartos
- Contact Person Email
- secretariat@clinicaccbr.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
- Department Name
- Sectia Clinica Neurologie
- Principal Investigator Name
- Any Axelerad
- Principal Investigator Email
- secretariat@spitalulconstanta.ro
- Contact Person Name
- Any Axelerad
- Contact Person Email
- secretariat@spitalulconstanta.ro
- Site Name
- Fizio Center S.R.L.
- Principal Investigator Name
- Elena Ifrim
- Principal Investigator Email
- studiiclinice@novalife.ro
- Contact Person Name
- Elena Ifrim
- Contact Person Email
- studiiclinice@novalife.ro
Spain
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 15-11-2024
- Processing Time Days
- 35
- Number Of Sites
- 9
- Number Of Participants
- 49
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Neurology
- Principal Investigator Name
- Maria Eugenia Bosca Blasco
- Principal Investigator Email
- bosca_mar@gva.es
- Contact Person Name
- Maria Eugenia Bosca Blasco
- Contact Person Email
- bosca_mar@gva.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Neurology
- Principal Investigator Name
- Margarita Sanchez del Rio Gonzalez
- Principal Investigator Email
- msanchezd@unav.es
- Contact Person Name
- Margarita Sanchez del Rio Gonzalez
- Contact Person Email
- msanchezd@unav.es
- Site Name
- Hospital Del Mar
- Department Name
- Neurology
- Principal Investigator Name
- Elisa Cuadrado Godia
- Principal Investigator Email
- ecuadrado@psmar.cat
- Contact Person Name
- Elisa Cuadrado Godia
- Contact Person Email
- ecuadrado@psmar.cat
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Neurology
- Principal Investigator Name
- Isabel Beltran Blasco
- Principal Investigator Email
- beltran_isabla@gva.es
- Contact Person Name
- Isabel Beltran Blasco
- Contact Person Email
- beltran_isabla@gva.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Samuel Diaz Insa
- Principal Investigator Email
- diaz_sam@gva.es
- Contact Person Name
- Samuel Diaz Insa
- Contact Person Email
- diaz_sam@gva.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Neurology
- Principal Investigator Name
- Alejandro Barroso Merinero
- Principal Investigator Email
- abarroso@hmhospitales.com
- Contact Person Name
- Alejandro Barroso Merinero
- Contact Person Email
- abarroso@hmhospitales.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 Del Mar (duplicate reference in list)
- Department Name
- Neurology
- Principal Investigator Name
- Elisa Cuadrado Godia
- Principal Investigator Email
- ecuadrado@psmar.cat
- Contact Person Name
- Elisa Cuadrado Godia
- Contact Person Email
- ecuadrado@psmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia (duplicate reference)
- Department Name
- Neurology
- Principal Investigator Name
- Maria Eugenia Bosca Blasco
- Principal Investigator Email
- bosca_mar@gva.es
- Contact Person Name
- Maria Eugenia Bosca Blasco
- Contact Person Email
- bosca_mar@gva.es
Hungary
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 24-07-2024
- Processing Time Days
- 54
- Number Of Sites
- 1
- Number Of Participants
- 21
Sites
- Site Name
- S-Medicon Kft.
- Principal Investigator Name
- Mária Sátori
- Principal Investigator Email
- satori.maria@gmail.com
- Contact Person Name
- Mária Sátori
- Contact Person Email
- satori.maria@gmail.com
Sponsor
Primary sponsor
- Full Name
- H. Lundbeck A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: [6]
- Name
- Celerion Switzerland AG
- Responsibilities
- sponsorDuties codes: [4]
- Name
- WCG Clinical Inc.
- Responsibilities
- sponsorDuties codes: [7]
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [1,12,13,14,15,2,3,4,5,8]; includes ECG (code 15)
- Name
- Azenta US Inc.
- Responsibilities
- sponsorDuties codes: [15]; Analysis
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,13,14,15,2,3,4,5,8]; noted value: ECG for code 15","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: [15]; noted value: Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Swarn Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Lu AG09222
- Active Substance
- LU AG09222
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Investigational
- Dose Levels
- up to 4 dose levels
- Frequency
- Baseline, Week 4, Week 8 (three doses over 8 weeks)
- Investigational Product Name
- Placebo to match IMP Lu AG09222
- Modality
- Other
- Authorisation Status
- Investigational
- Frequency
- Administered to match active schedule (Baseline, Week 4, Week 8)
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