이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

급성뇌허혈성뇌졸중 환자에서 소바텔타이드의 안전성 및 유효성 평가를 위한 연구 (RESPECT-ETB)

2026년 11월 9일 업데이트: Pharmazz, Inc.

급성 뇌 허혈성 뇌졸중 환자에서 Sovateltide의 안전성과 효능을 평가하기 위한 다심, 무작위, 이중 맹검, 평행, 위약 대조 3상 연구.

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

A stroke is a syndrome defined as an abrupt neurological outburst due to impaired blood flow to part of the brain. There are two types of stroke: hemorrhagic stroke and ischemic stroke. A hemorrhagic stroke follows the rupture of a weakened blood vessel in the brain causing accumulation of blood and compression of the surrounding brain tissue. An ischemic stroke follows a blocked blood vessel by a thrombus (blood clot) or embolism. In both types of strokes, the specific region of the brain supplied by the affected blood vessel is deprived of oxygenated blood, causing local hypoxia that damages the brain tissue and cells. Both types of stroke are very serious, however ischemic stroke is more common.

The global burden of ischemic stroke is nearly 4-fold greater than hemorrhagic stroke with close to 87% of the total incidence of stroke attributed to acute cerebral ischemic stroke (ACIS). ACIS is a critical care emergency caused by a significant reduction in blood flow to the brain by a blood clot or embolism. This nearly halts cerebral blood flow to the affected region leading to neuronal death. Neuronal cell death is followed by plasma membrane disruption, swelling of organelles, leaking of cell contents into extracellular space, and loss of neuronal function. Other events that take place include inflammation, excitotoxicity, free radical mediated toxicity, cytokine mediated cytotoxicity, impaired blood-brain-barrier, and oxidative stress.

Therapeutic management of ACIS is a multidisciplinary approach with a primary goal of revascularization and limiting neuronal injury. A stroke team consists of emergency medicine physicians, neurologists/neurosurgeons, radiologists, nurses and advanced care providers, clinical pharmacists, therapists, technicians, and laboratory personnel. Currently, the only FDA-approved pharmacological agent for ischemic stroke is tissue plasminogen activator (t-PA). It is a thrombolytic agent which restores blood flow by breaking down a clot. However, timing is crucial in administration of t-PA as the therapeutic time window is very narrow and the patient must receive it within 4.5 hours of onset of stroke symptoms. Therapeutic administration after this timeframe can result in hemorrhagic transformation, leading to additional brain damage. Nevertheless, even upon timely administration of t-PA in ACIS, only about 30% of patients obtain stroke resolution having minimal or no disability at the 90-day mark.

Sovateltide (PMZ-1620, IRL-1620) is a highly selective ETB receptor agonist and a synthetic analog of ET-1. Studies conducted to determine the effects brought about by sovateltide upon its interaction with neural ETB receptors and have found that it enhances angiogenesis and neurogenesis as well as promotes neural repair and regeneration. In a rat model of ischemic stroke, sovateltide was found to be neuroprotective as well as enhance angiogenic and neurogenic remodeling. Sovateltide significantly improved survival, reduced neurological and motor function deficit, while effectively decreasing infarct volume, edema, and oxidative stress.

Sovateltide was also found to be safe and well tolerated in healthy human volunteers in a phase I clinical trial (CTRI/2016/11/007509). A phase II study was also conducted in patients with acute ischemic stroke where sovateltide demonstrated significant improvement when compared to standard of care (CTRI/2017/11/010654, NCT04046484). A recent phase III study conducted in patients of acute ischemic stroke demonstrated improved favorable functional and neurological outcome at 3 months compared to standard of care (CTRI/2019/09/021373, NCT04047563).

Clinical phase II and III results indicate that sovateltide is a first-in-class neuronal progenitor cell therapeutic that promotes quick recovery and significantly improves neurological outcomes in cerebral ischemic stroke patients. With this convincing evidence, the plan is to conduct a multicentric, randomized, double-blind, parallel, placebo-controlled phase III clinical study in the United States, Canada, United Kingdom and Europe (the demographics and standard of treatment being similar in these countries) to further assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.

연구 유형

중재적

등록 (추정된)

514

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Anil Gulati, MD, PhD
전화번호: 6307806087
이메일: anil.gulati@pharmazz.com

연구 연락처 백업

이름: Neil Marwah, MD
전화번호: 6307806087
이메일: neil.marwah@pharmazz.com

연구 장소

독일
- - Bad Neustadt an der Saale, 독일, 97616
    - 모병
    - RHON-KLINIKUM Campus Bad Neustadt
    - 연락하다:
      
      Soda, Hassan
      
      이메일: h.soda.akut@neurologie-bad-neustadt.de
  - Erlangen, 독일, 91054
    - 모병
    - Universitaetsklinikum Erlangen
    - 연락하다:
      
      Gerner, Stefan
      
      이메일: stefan.gerner@uk-erlangen.de
  - Essen, 독일, 45147
    - 모병
    - Universitätsklinikum Essen AöR
    - 연락하다:
      
      Prof. Dr. med. Martin Köhrmann
  - Lübeck, 독일, 23538
    - 모병
    - Universitätsklinikum Schleswig-Holstein AöR
    - 연락하다:
      
      Prof. Dr. George Royl
  - Tübingen, 독일
    - 모병
    - University Hospital Tuebingen
    - 연락하다:
      
      Mengel, Anne Rose
      
      이메일: Annerose.Mengel@med.uni-tuebingen.de
- Altenburg
  - Altenburg, Altenburg, 독일, 04600
    - 모병
    - Klinikum Altenburger Land GmbH
    - 연락하다:
      
      Joerg Berrouschot
- Lower Saxony
  - Göttingen, Lower Saxony, 독일, 37075
    - 모병
    - Universitaetsklinikum Goettingen
    - 연락하다:
      
      Ilko Maier
- Ludwigshafen Am
  - Rhein, Ludwigshafen Am, 독일, 67063
    - 모병
    - Klinikum der Stadt Ludwigshafen gGmbh
    - 연락하다:
      
      Dr Simon Nagel
- North Rhine-Westphalia
  - Minden, North Rhine-Westphalia, 독일, 32427
    - 모병
    - Muhlenkreiskliniken (MKK) - Johannes Wesling Klinikum Minden - Neurologische Klinik
    - 연락하다:
      
      Dr Peter Schellinger
- Recklinghausen
  - Recklinghausen, Recklinghausen, 독일, 45657
    - 모병
    - Klinik fuer Neurologie, Stroke Unit und Fruehrehabilitation Dorstener Strae 151
    - 연락하다:
      
      Dr Stephan Klebe
- State of Berlin
  - Berlin, State of Berlin, 독일, 12203
    - 모병
    - Charite-Universitaetsmedizin Berlin
    - 연락하다:
      
      Christian Nolte
      
      이메일: christian.nolte@charite.de
미국
- Arizona
  - Tucson, Arizona, 미국, 85719
    - 모병
    - The University of Arizona - College of Medicine
    - 연락하다:
      
      Kaddouh, Firas
      
      이메일: firaskaddouh@arizona.edu
- California
  - Carmichael, California, 미국, 95608
    - 모병
    - Mercy Medical Group
    - 연락하다:
      
      Lucian Maidan, MD
  - Oxnard, California, 미국, 93030
    - 모병
    - St. John's Regional Medical Center
    - 연락하다:
      
      Mani Nezhad
- Florida
  - Sarasota, Florida, 미국, 34239
    - 모병
    - Sarasota Memorial Hospital
    - 연락하다:
      
      Dr. Mauricio Concha
- Georgia
  - Marietta, Georgia, 미국, 30060
    - 모병
    - Wellstar Kennestone Hospital
    - 연락하다:
      
      Dr. Ovais Inamullah
- Missouri
  - Bridgeton, Missouri, 미국, 63044
    - 모병
    - SSM Health Neurosciences
    - 연락하다:
      
      Amer Alshekhlee, MD
- New Jersey
  - Paramus, New Jersey, 미국, 07652
    - 모병
    - Hackensack University Medical Center at Paramus
    - 연락하다:
      
      Amory, Colum
      
      이메일: colum.amory@hmhn.org
- North Carolina
  - Chapel Hill, North Carolina, 미국, 27514
    - 모병
    - UNC Medical Center
    - 연락하다:
      
      Dr. Ho, James
  - Greensboro, North Carolina, 미국, 27401
    - 모병
    - Guilford Neurologic Associates Inc
    - 연락하다:
      
      Dr. Pramod Sethi
- Ohio
  - Columbus, Ohio, 미국, 43210
    - 모병
    - OSU Wexner Medical Center
    - 연락하다:
      
      Yousef Hannawi
- Pennsylvania
  - Hershey, Pennsylvania, 미국, 17033
    - 모병
    - Penn State Health Milton S. Hershey Medical Center
    - 연락하다:
      
      Reichwein, Raymond
      
      이메일: rreichwein@pennstatehealth.psu.edu
  - Pittsburgh, Pennsylvania, 미국, 15213
    - 모병
    - UPMC Presbyterian Hospital
    - 연락하다:
      
      Dr Jussie Correia Lima
- Tennessee
  - Chattanooga, Tennessee, 미국, 37404
    - 모병
    - CHI Memorial Neuroscience Institute
    - 연락하다:
      
      Thomas Devlin
- Texas
  - Houston, Texas, 미국, 77030
    - 모병
    - Baylor College of Medicine
    - 연락하다:
      
      Dr. Rao, Chethan
  - Houston, Texas, 미국, 77030
    - 모병
    - Memorial Hermann Hospital
    - 연락하다:
      
      Mahan Shahrivari, MD
  - Houston, Texas, 미국, 77030
    - 모병
    - Houston Medical Neurological Institute
    - 연락하다:
      
      David Chui, MD
스페인
- - A Coruña, 스페인, 15006
    - 모병
    - Instituto de Investigación Biomédica de A Coruña
    - 연락하다:
      
      Dr Maria del Mar Castellanos Rodrigo
  - Badajoz, 스페인, 06080
    - 모병
    - Hospital Universitario Infanta Cristina (HUB)
    - 연락하다:
      
      Dr Jose Maria Ramirez Moreno
  - Barakaldo, 스페인, 48903
    - 모병
    - Hospital Universitario de Cruces
    - 연락하다:
      
      Dr Mari Mar Freijo Guerrero
  - Girona, 스페인, 17007
    - 모병
    - Institut Catala d'Oncologia (ICO) - Hospital Universitari Doctor Josep Trueta
    - 연락하다:
      
      Dr Yolanda Silva Blas
  - Madrid, 스페인, 28034
    - 모병
    - Hospital Universitario Ramon y Cajal
    - 연락하다:
      
      Dr Jaime Masjuan Vallejo
  - Madrid, 스페인, 28040
    - 모병
    - Hospital Clinico San Carlos
    - 연락하다:
      
      Dr Jose Antonio Egido Herrero
  - Melilla, 스페인, 52001
    - 모병
    - Medical Imbrain S.L.
    - 연락하다:
      
      Romero Imbroda, Jesus
      
      이메일: jesusromeroimbroda@gmail.com
  - Santiago, 스페인, 15706
    - 모병
    - Hospital Clinico Universitario de Santiago
    - 연락하다:
      
      Dr Manuel Rodriguez Yanez
  - Seville, 스페인, 41013
    - 모병
    - Hospital Universitario Virgen del Rocio
    - 연락하다:
      
      Dr Francisco Moniche Alvarez
  - Valencia, 스페인, 46026
    - 모병
    - Hospital Universitari i Politecnic La Fe de Valencia
    - 연락하다:
      
      Dr Irene Escudero Martinez
  - Valencia, 스페인, 46010
    - 모병
    - Hospital Clinico Universitario de Valencia
    - 연락하다:
      
      Dr. Alejandro Ponz
  - Zaragoza, 스페인, 50009
    - 모병
    - Hospital Universitario Miguel Servet
    - 연락하다:
      
      Dr Herbert Tejada Meza
- Barcelona
  - Badalona, Barcelona, 스페인, 08916
    - 모병
    - Hospital Germans Trias i Pujol
    - 연락하다:
      
      María Hernández Pérez
  - Barcelona, Barcelona, 스페인, 08035
    - 모병
    - Hospital Universitari Vall d'Hebron
    - 연락하다:
      
      Carlos Alberto Molina Cateriano
- Castille-La Mancha
  - Albacete, Castille-La Mancha, 스페인, 2006
    - 모병
    - Complejo Hospitalario Universitario de Albacete
    - 연락하다:
      
      Dr Tomas Segura Martin
- Madrid
  - Madrid, Madrid, 스페인, 28046
    - 모병
    - Hospital Universitario La Paz
    - 연락하다:
      
      Exuperio Díez Tejedor
  - Madrid, Madrid, 스페인, 28222
    - 모병
    - Hospital Universitario Puerta de Hierro Majadahonda
    - 연락하다:
      
      Dr Joaquin Carneado Ruiz
- Murcia
  - El Palmar, Murcia, 스페인, 30120
    - 모병
    - Hospital Clínico Universitario Virgen de Arrixaca
    - 연락하다:
      
      Dr Ana Morales Ortiz
- Sevilla
  - Seville, Sevilla, 스페인, 41009
    - 모병
    - Hospital Universitario Virgen Macarena
    - 연락하다:
      
      Soledad Pérez Sánchez
- Tarragona
  - Tarragona, Tarragona, 스페인, 43005
    - 모병
    - Hospital Universitari Joan XXIII
    - 연락하다:
      
      Dr Xavier Ustrell Roig
영국
- - Harrow, 영국, HA1 3UJ
    - 모병
    - London North West University Healthcare NHS Trust - Northwick Park Hospital
    - 연락하다:
      
      Sivagnanaratnam, Aravinth
      
      이메일: a.sivagnanaratnam@nhs.net
  - Newcastle, 영국, NE1 4LP
    - 모병
    - Hospitals NHS Foundation Trust - Royal Victoria Infirmary RVI
    - 연락하다:
      
      Dr. Anand Dixit
  - Stoke-on-Trent, 영국, ST4 6QG
    - 모병
    - Royal Stoke University Hospital
    - 연락하다:
      
      Ferdinand, Phillip
      
      이메일: phillip.ferdinand@uhnm.nhs.uk
- Bury
  - Bury, Bury, 영국, BL9 7TD
    - 모병
    - Fairfield General Hospital
    - 연락하다:
      
      Dr Narayanamoorthi Saravanan
- London
  - London, London, 영국, NW1 2BU
    - 모병
    - National Hospital for Neurology & Neurosurgery
    - 연락하다:
      
      Dr Richard Perry
  - London, London, 영국, SE5 9RS
    - 모병
    - King's College Hospital NHS Foundation Trust
    - 연락하다:
      
      Dr Yee Mah
  - London, London, 영국, SW17 0QT
    - 모병
    - St. George's University Hospitals
    - 연락하다:
      
      Zhang, Liqun
      
      이메일: liqun.zhang@stgeorges.nhs.uk
- Southampton
  - Southampton, Southampton, 영국, SO16 6YD
    - 모병
    - University Hospital Southampton
    - 연락하다:
      
      Dr Richard Marigold
- Wolverhampton
  - Wolverhampton, Wolverhampton, 영국, WV10 0QP
    - 모병
    - New Cross Hospital - Royal Wolverhampton NHS Trust
    - 연락하다:
      
      Dr Nasar Ahmad
호주
- New South Wales
  - Liverpool, New South Wales, 호주, 2170
    - 모병
    - Liverpool Hospital
    - 연락하다:
      
      Dr. Cordato, Dennis
      
      이메일: dennis.cordato@health.nsw.gov.au

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:

Adult males or females aged 18 - 80 years of age.
Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
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.
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.
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.
Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:

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.
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).
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.
Known pregnancy and lactating women.
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.
Concurrent participation in any other therapeutic clinical trial.
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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
활성 비교기: Normal Saline + Standard of care Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.	의약품: Drug: Normal Saline Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke. 다른 이름들: 차량
실험적: Sovateltide + Standard of care The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.	의약품: Sovateltide Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke. 다른 이름들: PMZ-1620

참가자 그룹 / 팔

개입 / 치료

활성 비교기: Normal Saline + Standard of care

Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

의약품: Drug: Normal Saline

Normal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.

다른 이름들:

차량

실험적: Sovateltide + Standard of care

The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

의약품: Sovateltide

Phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.

다른 이름들:

PMZ-1620

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Determine the efficacy of sovateltide in patients with acute cerebral ischemic stroke assessed by modified Rankin Scale (mRS) score of 0-2 at day 90 post-randomization. 기간: Day 1 through Day 90	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.	Day 1 through Day 90

2차 결과 측정

결과 측정	측정값 설명	기간
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the National Institute of Health Stroke Scale (NIHSS) score of <6 at day 90 post-randomization. 기간: Day 1 through Day 90	The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 90 post-randomization.	Day 1 through Day 90
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the Barthel Index (BI) score of ≥90 at day 90 post-randomization. 기간: Day 1 through Day 90	The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization.	Day 1 through Day 90
Determine an excellent functional outcome in patients with acute cerebral ischemic stroke assessed by a modified Rankin Scale score of 0-1 at day 90 post-randomization. 기간: Day 1 through Day 90	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.	Day 1 through Day 90
Determine a change in Quality-of-life (QoL) as assessed by EuroQol-EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at days 30, 60, and 90 post-randomization. 기간: Day 1 through Day 90	Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization.	Day 1 through Day 90
Determine the incidence of recurrent cerebral ischemic stroke within 90 days post-randomization. 기간: Day 1 through Day 90	The proportion of patients with recurrent ischemic stroke within 90 days post-randomization.	Day 1 through Day 90
Determine the incidence of mortality within 90 days post-randomization. 기간: Day 1 through Day 90	Number of deaths within day 90 post-randomization.	Day 1 through Day 90
Determine the incidence of symptomatic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization. 기간: Day 1 through Day 90	The proportion of patients with symptomatic ICH within 24 (± 6) hours of randomization.	Day 1 through Day 90
Determine the incidence of radiographic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization. 기간: Day 1 through Day 90	The proportion of patients with radiographic ICH within 24 (± 6) hours of randomization.	Day 1 through Day 90
Determine alteration in cognition at days 30 and 90 measured by Montreal Cognitive Assessment (MoCA) Test. 기간: Day 1 through Day 90	Change in MoCA score at days 30 and 90 post-randomization.	Day 1 through Day 90
Determine any adverse events (AE) or serious adverse events (SAEs) are associated with sovateltide. 기간: Day 1 through Day 90	The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).	Day 1 through Day 90

기타 결과 측정

결과 측정	측정값 설명	기간
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by mRS score of 0-2 at day 30 post-randomization. 기간: Day 1 through Day 30	The proportion of acute cerebral ischemic stroke patients having a good functional outcome with a mRS score of 0-2 on day 30 post-randomization.	Day 1 through Day 30
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the NIHSS score of <6 at day 30 post-randomization. 기간: Day 1 through Day 30	The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 30 post-randomization.	Day 1 through Day 30
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the BI score of ≥90 at day 30 post-randomization. 기간: Day 1 through Day 30	The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 30 post-randomization.	Day 1 through Day 30
Determine Alberta Stroke Program Early CT (ASPECT) Score for stroke severity at baseline and identify sites of ischemic lesions. 기간: Day 1 through Day 90	Compare baseline Alberta Stroke Program Early CT (ASPECT) Score for stroke severity and identify sites of ischemic lesions.	Day 1 through Day 90
Determine the subtype of acute cerebral ischemic stroke according to TOAST classification at day 30 post-randomization. 기간: Day 1 through Day 30	Compare the subtype of acute cerebral ischemic stroke by TOAST classification at day 30 post-randomization.	Day 1 through Day 30

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pharmazz, Inc.

수사관

연구 의자: Anil Gulati, MD, PhD, Pharmazz, Inc.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 24일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2023년 1월 11일

QC 기준을 충족하는 최초 제출

2023년 1월 11일

처음 게시됨 (실제)

2023년 1월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

엔도텔린 B 수용체

추가 관련 MeSH 약관

기타 연구 ID 번호

Sovateltide/ACIS/IND2022

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Following completion of the trial in 2027, the anonymized patient datasets created and/or analyzed for the current study can be accessed from the corresponding author at a reasonable request from a bona fide researcher/research group.

IPD 공유 기간

December 2027

IPD 공유 액세스 기준

IPD 공유 지원 정보 유형

연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

급성뇌허혈성뇌졸중 환자에서 소바텔타이드의 안전성 및 유효성 평가를 위한 연구 (RESPECT-ETB)

급성 뇌 허혈성 뇌졸중 환자에서 Sovateltide의 안전성과 효능을 평가하기 위한 다심, 무작위, 이중 맹검, 평행, 위약 대조 3상 연구.

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

연구 연락처 백업

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

간행물 및 유용한 링크

일반 간행물

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

IPD 공유 기간

IPD 공유 액세스 기준

IPD 공유 지원 정보 유형

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구