Clinical trial • Phase III • Neurology|Cardiology
SOVATELTIDE for Acute ischemic stroke
Phase III trial of SOVATELTIDE for Acute ischemic stroke.
Overview
- Trial Therapeutic Area
- Neurology|Cardiology
- Trial Disease
- Acute ischemic stroke
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-03-2025
- First CTIS Authorization Date
- 16-06-2025
Trial design
Randomised, sovateltide matching placebo (placebo comparator). active test: sovateltide (intravenous). product information notes max daily dose 0.9 µg/kg and max total dose 2.7 µg/kg; route intravenous. (no detailed dosing schedule text available in the provided json beyond max daily/total amounts.)-controlled Phase III trial in Germany, Spain.
- Randomised
- Yes
- Comparator
- Sovateltide matching placebo (placebo comparator). Active test: Sovateltide (intravenous). Product information notes max daily dose 0.9 µg/Kg and max total dose 2.7 µg/Kg; route intravenous. (No detailed dosing schedule text available in the provided JSON beyond max daily/total amounts.)
- Target Sample Size
- 190
- Trial Duration For Participant
- 90
Eligibility
Recruits 190 isVulnerablePopulationSelected = true. Consent requirement: "Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures". (No paediatric/assent procedures described; study enrols adults 18–80.).
- Pregnancy Exclusion
- Known pregnancy and lactating women
- Vulnerable Population
- isVulnerablePopulationSelected = true. Consent requirement: "Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures". (No paediatric/assent procedures described; study enrols adults 18–80.)
Inclusion criteria
- {"criterion_text":"- Adult males or females aged 18 – 80 years of age\n- Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures\n- A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.\n- Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20, NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.\n- The patient is <24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self- reported to be normal\n- Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits"}
Exclusion criteria
- {"criterion_text":"- Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.\n- Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2)\n- Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH) on the baseline CT or MRI scan\n- Known pregnancy and lactating women\n- Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator’s opinion, would confound the neurological and functional evaluations, lead to further deterioration of neurological status, or interfere with participation in this study\n- Concurrent participation in any other therapeutic clinical trial\n- Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or might cause harm to the patient"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary efficacy endpoint of the study is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale score of 0-2 on day 90 post-randomization.","definition_or_measurement_approach":"Good functional outcome defined as modified Rankin Scale (mRS) score of 0-2 measured on day 90 post-randomization."}
Secondary endpoints
- {"endpoint_text":"- The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 90 post-randomization.","definition_or_measurement_approach":"Good functional outcome defined as National Institute of Health Stroke Scale (NIHSS) score <6 at day 90 post-randomization."}
- {"endpoint_text":"- The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization.","definition_or_measurement_approach":"Good functional outcome defined as Barthel Index (BI) score ≥90 at day 90 post-randomization."}
- {"endpoint_text":"- The proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with a modified Rankin Scale score of 0-1 on day 90 post-randomization.","definition_or_measurement_approach":"Excellent functional outcome defined as mRS score 0-1 at day 90 post-randomization."}
- {"endpoint_text":"- Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization.","definition_or_measurement_approach":"Quality of life measured by EuroQol EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at baseline and days 30, 60, and 90."}
- {"endpoint_text":"- The proportion of patients with recurrent ischemic stroke within 90 days post-randomization.","definition_or_measurement_approach":"Incidence of recurrent ischemic stroke within 90 days after randomization."}
- {"endpoint_text":"- Number of deaths within day 90 post-randomization.","definition_or_measurement_approach":"All-cause mortality counted up to day 90 post-randomization."}
- {"endpoint_text":"- The proportion of patients with symptomatic ICH within 24 (± 6) hours of randomization.","definition_or_measurement_approach":"Incidence of symptomatic intracerebral hemorrhage (ICH) within 24 ±6 hours of randomization."}
- {"endpoint_text":"- The proportion of patients with radiographic ICH within 24 (± 6) hours of randomization.","definition_or_measurement_approach":"Incidence of radiographic intracerebral hemorrhage within 24 ±6 hours of randomization as shown on CT/MRI."}
- {"endpoint_text":"- Change in MoCA score at days 30 and 90 post-randomization.","definition_or_measurement_approach":"Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) at days 30 and 90 relative to baseline."}
- {"endpoint_text":"- The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).","definition_or_measurement_approach":"Incidence and proportion of patients experiencing AEs and SAEs during the study follow-up period (up to day 90)."}
Recruitment
- Planned Sample Size
- 262
- Recruitment Window Months
- 11
- Consent Approach
- Consent obtained per national laws and regulations and in accordance with applicable ethics committee requirements prior to study procedures. Subject information/informed consent form documents available in multiple languages (English, Spanish, German) as indicated by patient-facing documents and ICF attachments (e.g., L1_SIS and ICF_Main_ES, Patient Facing Document EN/ES/DE). Study enrols adults (18–80); no paediatric assent described.
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 262
Germany
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 318
- Number Of Sites
- 13
- Number Of Participants
- 100
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Neurology & Stroke
- Principal Investigator Name
- Annerose Mengel
- Principal Investigator Email
- annerose.mengel@med.uni-tuebingen.de
- Contact Person Name
- Annerose Mengel
- Contact Person Email
- annerose.mengel@med.uni-tuebingen.de
- Site Name
- Klinikum Vest GmbH
- Department Name
- NeuroCentrum
- Principal Investigator Name
- Stephan Klebe
- Principal Investigator Email
- stephan.klebe@knappschaft-kliniken.de
- Contact Person Name
- Stephan Klebe
- Contact Person Email
- stephan.klebe@knappschaft-kliniken.de
- Site Name
- Klinikum Altenburger Land GmbH
- Department Name
- Neurology
- Principal Investigator Name
- Jörg Berrouschot
- Principal Investigator Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Contact Person Name
- Jörg Berrouschot
- Contact Person Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Department of Neurology
- Principal Investigator Name
- Lars Marquardt
- Principal Investigator Email
- l.marquardt@asklepios.com
- Contact Person Name
- Lars Marquardt
- Contact Person Email
- l.marquardt@asklepios.com
- Site Name
- Muehlenkreiskliniken AöR
- Department Name
- Department of Neurology und Neurogeriatrics
- Principal Investigator Name
- Peter Schellinger
- Principal Investigator Email
- Peter.Schellinger@muehlenkreiskliniken.de
- Contact Person Name
- Peter Schellinger
- Contact Person Email
- Peter.Schellinger@muehlenkreiskliniken.de
- Site Name
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department Name
- Department of Neurology
- Principal Investigator Name
- Simon Nagel
- Principal Investigator Email
- nagelsi@klilu.de
- Contact Person Name
- Simon Nagel
- Contact Person Email
- nagelsi@klilu.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Department of Neurology
- Principal Investigator Name
- Ilko Maier
- Principal Investigator Email
- ilko.maier@med.uni-goettingen.de
- Contact Person Name
- Ilko Maier
- Contact Person Email
- ilko.maier@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Department of Neurology
- Principal Investigator Name
- Georg Royl
- Principal Investigator Email
- georg.royl@uni-luebeck.de
- Contact Person Name
- Georg Royl
- Contact Person Email
- georg.royl@uni-luebeck.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Neurology
- Principal Investigator Name
- Jan Scheitz
- Principal Investigator Email
- jan.scheitz@charite.de
- Contact Person Name
- Jan Scheitz
- Contact Person Email
- jan.scheitz@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of Neurology
- Principal Investigator Name
- Martin Köhrmann
- Principal Investigator Email
- martin.koehrmann@uk-essen.de
- Contact Person Name
- Martin Köhrmann
- Contact Person Email
- martin.koehrmann@uk-essen.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Department of Vascular Neurology
- Principal Investigator Name
- Lars Kellert
- Principal Investigator Email
- lars.kellert@med.uni-muenchen.de
- Contact Person Name
- Lars Kellert
- Contact Person Email
- lars.kellert@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Department of Neurology
- Principal Investigator Name
- Stefan Gerner
- Principal Investigator Email
- stefan.gerner@uk-erlangen.de
- Contact Person Name
- Stefan Gerner
- Contact Person Email
- stefan.gerner@uk-erlangen.de
- Site Name
- Rhoen-Klinikum AG
- Department Name
- Acute Neurology / Stroke Unit and Intensive Care
- Principal Investigator Name
- Hassan Soda
- Principal Investigator Email
- h.soda.akut@neurologie-bad-neustadt.de
- Contact Person Name
- Hassan Soda
- Contact Person Email
- h.soda.akut@neurologie-bad-neustadt.de
Spain
- Earliest CTIS Part Ii Submission Date
- 06-05-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 301
- Number Of Sites
- 20
- Number Of Participants
- 162
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Principal Investigator Name
- Soledad Perez Sanchez
- Principal Investigator Email
- soledad.perez.sanchez@gmail.com
- Contact Person Name
- Soledad Perez Sanchez
- Contact Person Email
- soledad.perez.sanchez@gmail.com
- Site Name
- Clinica De Neurociencias Imbrain S.L.P.
- Department Name
- Neurology
- Principal Investigator Name
- Jesus Romero Imbroda
- Principal Investigator Email
- jesusromeroimbroda@gmail.com
- Contact Person Name
- Jesus Romero Imbroda
- Contact Person Email
- jesusromeroimbroda@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Jaime Masjuan
- Principal Investigator Email
- jmasjuan.hrc@salud.madrid.org
- Contact Person Name
- Jaime Masjuan
- Contact Person Email
- jmasjuan.hrc@salud.madrid.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Irene Escudero
- Principal Investigator Email
- imesmar@gmail.com
- Contact Person Name
- Irene Escudero
- Contact Person Email
- imesmar@gmail.com
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Neurology
- Principal Investigator Name
- Tomas Segura
- Principal Investigator Email
- tseguram@gmail.com
- Contact Person Name
- Tomas Segura
- Contact Person Email
- tseguram@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Neurology
- Principal Investigator Name
- Jose Antonio Egido
- Principal Investigator Email
- jegidoh@yahoo.com
- Contact Person Name
- Jose Antonio Egido
- Contact Person Email
- jegidoh@yahoo.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Neurology
- Principal Investigator Name
- Maria del Mar Freijo
- Principal Investigator Email
- mariadelmar.freijoguerrero@osakidetza.eus
- Contact Person Name
- Maria del Mar Freijo
- Contact Person Email
- mariadelmar.freijoguerrero@osakidetza.eus
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Neurology
- Principal Investigator Name
- Manuel Rodriguez
- Principal Investigator Email
- manyanez@yahoo.es
- Contact Person Name
- Manuel Rodriguez
- Contact Person Email
- manyanez@yahoo.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Neurology
- Principal Investigator Name
- Maria Hernandez-Perez
- Principal Investigator Email
- mhernandezp.germanstrias@gencat.cat
- Contact Person Name
- Maria Hernandez-Perez
- Contact Person Email
- mhernandezp.germanstrias@gencat.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Carlos Alberto Molina
- Principal Investigator Email
- carlosav.molina@vallhebron.cat
- Contact Person Name
- Carlos Alberto Molina
- Contact Person Email
- carlosav.molina@vallhebron.cat
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Neurology
- Principal Investigator Name
- Yolanda Silva Blas
- Principal Investigator Email
- ysilva.girona.ics@gencat.cat
- Contact Person Name
- Yolanda Silva Blas
- Contact Person Email
- ysilva.girona.ics@gencat.cat
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Neurology
- Principal Investigator Name
- Jose Maria Ramirez
- Principal Investigator Email
- Josemaria.ramirez@salud-juntaex.es
- Contact Person Name
- Jose Maria Ramirez
- Contact Person Email
- Josemaria.ramirez@salud-juntaex.es
- Site Name
- Hospital Universitari Joan XXIII De Tarragona
- Department Name
- Neurology
- Principal Investigator Name
- Xavier Ustrell
- Principal Investigator Email
- xustrell.hj23.ics@gencat.cat
- Contact Person Name
- Xavier Ustrell
- Contact Person Email
- xustrell.hj23.ics@gencat.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Neurology
- Principal Investigator Name
- Joaquin Carneado Ruiz
- Principal Investigator Email
- jcarnead@gmail.com
- Contact Person Name
- Joaquin Carneado Ruiz
- Contact Person Email
- jcarnead@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology
- Principal Investigator Name
- Francisco Moniche
- Principal Investigator Email
- pmoniche@gmail.com
- Contact Person Name
- Francisco Moniche
- Contact Person Email
- pmoniche@gmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Neurology
- Principal Investigator Name
- Maria del Mar Castellanos Rodrigo
- Principal Investigator Email
- maria.del.mar.castellanos.rodrigo@sergas.es
- Contact Person Name
- Maria del Mar Castellanos Rodrigo
- Contact Person Email
- maria.del.mar.castellanos.rodrigo@sergas.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Neurology
- Principal Investigator Name
- Herbert Tejada Meza
- Principal Investigator Email
- htmeza@gmail.com
- Contact Person Name
- Herbert Tejada Meza
- Contact Person Email
- htmeza@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Neurology
- Principal Investigator Name
- Ana Morales
- Principal Investigator Email
- amoralesortiz@gmail.com
- Contact Person Name
- Ana Morales
- Contact Person Email
- amoralesortiz@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neurology
- Principal Investigator Name
- Exuperio Diez Tejedor
- Principal Investigator Email
- exuperio.diez@salud.madrid.org
- Contact Person Name
- Exuperio Diez Tejedor
- Contact Person Email
- exuperio.diez@salud.madrid.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Neurology
- Principal Investigator Name
- Alejandro Ponz
- Principal Investigator Email
- ponz_ale@gva.es
- Contact Person Name
- Alejandro Ponz
- Contact Person Email
- ponz_ale@gva.es
Sponsor
Primary sponsor
- Full Name
- Pharmazz EU Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Sponsor duties codes: 1,10,12,13,2,5,6,8
- Name
- PPD Development LP
- Responsibilities
- Sponsor duties codes: 4
- Name
- Fisher Clinical Services Inc.
- Responsibilities
- Sponsor duties codes: 14
Third parties
- {"country":"United Kingdom","full_name":"Neonstone Limited","duties_or_roles":"Scales and tests training and data management","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Trial Master File","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Sovateltide
- Active Substance
- SOVATELTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus=1
- Maximum Dose
- Max daily dose 0.9 µg/Kg; max total dose 2.7 µg/Kg
- Investigational Product Name
- Sovateltide matching placebo
- Modality
- Other
Related trials
Other published trials that may interest you.