Ischemic Stroke Clinical Trial
— RODINOfficial title:
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Nelonemdaz in Patients With Acute Ischemic Stroke
Verified date | September 2021 |
Source | GNT Pharma |
Contact | Chun San An |
Phone | 82-31-8005-9910 |
csan[@]gntpharma.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute ischemic stroke patients receiving endovascular treatment to remove clot within 12 hours following stroke onset. Neu2000KWL will be administered before endovascular treatment.
Status | Recruiting |
Enrollment | 496 |
Est. completion date | January 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: The trial subjects should satisfy all the following criteria. 1. Adults=19 years 2. Patients who can start endovascular therapy within 12 hours after the symptomatic onset of Ischemic stroke. 3. NIHSS on screening time point = 8 points 4. Patients whose general condition was favorable enough to perform daily activities without the help of others one day prior to the ischemic stroke onset (a person with mRS 0 or 1) 5. Patients whose CTA or MRA confirmed internal carotid artery occlusion and M1 or M2 occlusion of the middle cerebral artery, that are the types of major cerebral artery occlusion that can cause acute cerebral infarction and are subject to endovascular therapy. 6. Patients with early ASPECTS point=4 (Noncontrast brain cross-section CT or Brain cross-section MRI diffusion weighted imaging) 7. Patients who spontaneously submitted a written informed consent to participation on this clinical study. Exclusion Criteria: A patient who meets any one of the conditions below cannot participate in the Clinical trial. 1. Patients who meet the following exclusion criteria on imaging of endovascular therapy ? Patients whose occlusion location that can cause an acute ischemic stroke in the CTA (CT angiography) image meets under the following conditions: A. Occlusion of bilateral large artery B. Simultaneous infiltration of anterior and posterior circulation 2. Patients who have contraindication to contrast media for brain imaging. 3. Patients who are receiving renal replacement therapy such as dialysis due to acute or terminal nephropathy at screening point. 4. Patients who were diagnosed with cancer or received cancer therapy within 6 months at screening or have recurrent or transitional cancer. 5. Patients have high body temperature of 38oC or more and need antibiotic therapy due to medical opinion of infectious disease at screening. 6. Patients who are having pharmacotherapy due to liver diseases such as hepatic cirrhosis, etc. at screening point. 7. Patients who are pregnant or lactating. However, only a woman who has no possibility of pregnancy can participate in this clinical research. Woman with child-bearing potential can be defined as the woman who has not had the clear menopause or who has not had surgical treatment that makes pregnancy impossible. 8. Patients who have participated in other clinical trial within past 6 months at the screening time as a base. However, in case of participation of observatory experiment, the patient can participate in this clinical trial. 9. Patients who are determined unsuitable for participation in this clinical trial due to other reasons |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Gyeongsang National University Hospital | Changwon | |
Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Daejeon Eulji Medical Center, Eulji University | Daejeon | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Chosun University Hospital | Gwangju | |
Korea, Republic of | Hallym University Dongtan Sacred Heart hospital | Hwaseong | |
Korea, Republic of | Wonkwang University Hospital | Iksan | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | Jeju National University Hospital | Jeju | |
Korea, Republic of | Jeonbuk National University Hospital | Jeonju | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Ewha womans University Seoul Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Kyunghee University Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Korea, Republic of | Yongin Severance Hospital | Yongin |
Lead Sponsor | Collaborator |
---|---|
GNT Pharma |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of adverse events and serious adverse events | day0~week12 | ||
Other | All mortality rate until 12 weeks | day0~week12 | ||
Primary | mRS score evaluated at 12 week after the first dose of drug (Nelonemdaz or Placebo). | week12 | ||
Secondary | Proportion of mRS 0-2 evaluated at week 5 and week 12 after the first dose of drug (Nelonemdaz or Placebo). | week5, week12 | ||
Secondary | mRS score evaluated at week 5 after the first dose of investigational drug (Nelonemdaz or Placebo). | week5 | ||
Secondary | Proportion of mRS 0 measured at week 5 and week 12 after the first dose of investigational drug (Nelonemdaz or Placebo). | week5, week12 | ||
Secondary | Proportion of NIHSS 0-4 evaluated within 24 hours (Within 72 hours if weekend is included), 5 week, 12 week after the last injection of drug. (Evaluating 43 points for deaths) | 24hour(or 72hour), week5, week12 | ||
Secondary | Volume of Ischemic stroke based on brain MRI diffusion weighted imaging within 24 hours and at week 12. (If MRI is not available, reading will be performed based on CT scan.) | 24hour, week12 | ||
Secondary | Proportion of Barthel Index=95 evaluated at week 5 and week 12 | week5, week12 | ||
Secondary | Occurrence rate of Symptomatic intracranial hemorrhage (SICH) described and defined by this study occurring within 24 hours after the last injection | [Definition of Symptomatic intracranial hemorrhage (SICH)] In the case that brain imaging confirms intracranial hemorrhage with neurological deterioration. (NIHSS score=4 points) neurological deterioration. (NIHSS score=4 points) | 24hour |
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