Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial
NCT ID: NCT06429384
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2023-06-04
2023-12-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants.
Subjects press 1:1:1: 1 ratio of patients were randomly divided into Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60mg/ time, qd) and placebo control group, with 60 cases in each group. Random stratification factors include:
Time of onset (≤24 hours, \> 24 hours). The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.
The trial was divided into three phases: screening/baseline, treatment, and follow-up.
Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.
Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.
Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.
Stroke-related scale scores were performed at 10, 30, and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale (MSAS) and Hamilton Anxiety Scale (HAMA) were performed on the 10th and 90th days after the use of experimental drugs. Adverse events were recorded during treatment and follow-up to further assess safety
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Y-3 for Injection in the Treatment of Acute Ischemic Stroke
NCT06517173
Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke
NCT04950920
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
NCT06755944
Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke
NCT07040085
EFfects of Y-6 SUblingual Tablets foR PaTients With AcUte Ischemic StRokE (FUTURE)
NCT06138834
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Random stratification factors included: onset time (≤24 hours, \> 24 hours).The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose.
The trial was divided into three phases:screening/baseline, treatment, and follow-up.
Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.Stroke-related scale scores were performed on the 10th, 30th and 90th days after the first use of the experimental drug, and Montgomery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAMA) scores were performed on the 10th and 90th days after the first use of the experimental drug. Adverse events were recorded during treatment and follow-up to further assess safety.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Y-3 low-dose group (20 mg/dose, qd)
Y-3 injection 20mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Y-3 Injection/Y-3 blank injection
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Y-3 medium dose group (40 mg/dose, qd)
Y-3 injection 40mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Y-3 Injection/Y-3 blank injection
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Y-3 high-dose group (60 mg/dose, qd)
Y-3 injection 60mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
Y-3 Injection/Y-3 blank injection
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Blank control group
Y-3 blank injection 10ml was diluted with about 250 ml normal saline, intravenous infusion, qd, and continuous medication for 10 days.
Y-3 Injection/Y-3 blank injection
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Y-3 Injection/Y-3 blank injection
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Only those who meet all the following criteria can be included in the group:
1. Age ≥ 18 years old and\<81 years old, regardless of gender;
2. After the onset of this disease, the National Institutes of Research Stroke Scale score was 6 ≤ NIHSS ≤ 20 points, and the sum of the 5th upper limb and 6th lower limb scores was ≥ 2 points. If patients receiving thrombolysis treatment were screened and evaluated based on the NIHSS score after thrombolysis;
3. Within 48 hours (including 48 hours) of onset;
4. Diagnosed as ischemic stroke according to the "Key Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019", with good recovery after the first or last onset (mRS score ≤ 1 point before this onset);
5. Obtain informed consent from the patient or their legal representative voluntarily signed and approved by the ethics committee.
Exclusion Criteria
Those who meet one of the following criteria during filtering cannot be included in the group:
1. Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment;
2. Severe consciousness disorder: The item score of NIHSS's 1a consciousness level is greater than 1 point;
3. Transient ischemic attack (TIA);
4. After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
5. Previously diagnosed patients with severe mental disorders and severe dementia;
6. Patients previously diagnosed with depression or anxiety disorder;
7. Patients undergoing antidepressant or anti anxiety treatment;
8. Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc; Or ALT or AST\>2.0 × ULN;
9. Diagnosed with severe active kidney disease or renal insufficiency; Or serum creatinine\>1.5 × ULN;
10. After the onset of the disease, drugs with brain cytoprotection in the instructions have been used, such as edaravone, concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, CDPC, piracetam, oxiracetam, butylphenylpeptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (cerebroprotein hydrolysate), calf serum deproteinized injection Calf blood deproteinized extract injection, etc;
11. After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;
12. Previously diagnosed with concurrent malignant tumors and undergoing anti-tumor treatment;
13. Previously diagnosed with severe systemic diseases, with an estimated survival period of\<90 days;
14. The patient is in pregnancy, lactation, and there is a possibility of pregnancy in the patient/patient partner who plans to conceive during the trial period;
15. Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide);
16. A history of major surgeries within 4 weeks prior to enrollment and assessed by the researcher as affecting neurological function scores or affecting 90 day survival;
17. Have participated in other clinical studies or are currently participating in other clinical studies within the first 30 days of randomization;
18. The researcher believes that it is not suitable to participate in this clinical study.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurodawn Pharmaceutical Co., Ltd.
INDUSTRY
Beijing Tiantan Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yongjun Wang
Chief Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shuya Li
Role: STUDY_DIRECTOR
IRB of Beijing Tiantan Hospital Capital Medical University Beijing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, China
Liuzhou Workers Hospital
Liuzhou, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Daqing People's Hospital
Daqing, Heilongjiang, China
Nanyang Second People's Hospital
Nanyang, Henan, China
Nanyang South Stone Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China
Inner Mongolia Baotou Steel Hospital
Baotou, Inner Mongolia, China
Inner Mongolia International Mongolian Medicine Hospital
Hohhot, Inner Mongolia, China
Huai 'an First People's Hospital
Huai'an, Jiangsu, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China
Lianyungang Second People's Hospital
Lianyungang, Jiangsu, China
Taizhou Second People's Hospital
Taizhou, Jiangsu, China
Xuzhou Central Hospital (Old Hospital Area)
Xuzhou, Jiangsu, China
Xuzhou Central Hospital（New compound）
Xuzhou, Jiangsu, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Beipiao Central Hospital
Beipiao, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Chinese People's Liberation Army Northern Theater Command General Hospital
Shenyang, Liaoning, China
Shenyang First People's Hospital
Shenyang, Liaoning, China
Shandong Third Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Tancheng County First People's Hospital
Linyi, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Dongyang City People's Hospital
Dongyang, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.
Emberson J, Lees KR, Lyden P, Blackwell L, Albers G, Bluhmki E, Brott T, Cohen G, Davis S, Donnan G, Grotta J, Howard G, Kaste M, Koga M, von Kummer R, Lansberg M, Lindley RI, Murray G, Olivot JM, Parsons M, Tilley B, Toni D, Toyoda K, Wahlgren N, Wardlaw J, Whiteley W, del Zoppo GJ, Baigent C, Sandercock P, Hacke W; Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014 Nov 29;384(9958):1929-35. doi: 10.1016/S0140-6736(14)60584-5. Epub 2014 Aug 5.
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
van Horn N, Kniep H, Leischner H, McDonough R, Deb-Chatterji M, Broocks G, Thomalla G, Brekenfeld C, Fiehler J, Hanning U, Flottmann F. Predictors of poor clinical outcome despite complete reperfusion in acute ischemic stroke patients. J Neurointerv Surg. 2021 Jan;13(1):14-18. doi: 10.1136/neurintsurg-2020-015889. Epub 2020 May 15.
Lee SH, Kim BJ, Han MK, Park TH, Lee KB, Lee BC, Yu KH, Oh MS, Cha JK, Kim DH, Nah HW, Lee J, Lee SJ, Kim JG, Park JM, Kang K, Cho YJ, Hong KS, Park HK, Choi JC, Kim JT, Choi K, Kim DE, Ryu WS, Kim WJ, Shin DI, Yeo M, Sohn SI, Hong JH, Lee J, Lee JS, Khatri P, Bae HJ. Futile reperfusion and predicted therapeutic benefits after successful endovascular treatment according to initial stroke severity. BMC Neurol. 2019 Jan 15;19(1):11. doi: 10.1186/s12883-019-1237-2.
Meyer L, Alexandrou M, Leischner H, Flottmann F, Deb-Chatterji M, Abdullayev N, Maus V, Politi M, Roth C, Kastrup A, Thomalla G, Mpotsaris A, Fiehler J, Papanagiotou P. Mechanical thrombectomy in nonagenarians with acute ischemic stroke. J Neurointerv Surg. 2019 Nov;11(11):1091-1094. doi: 10.1136/neurintsurg-2019-014785. Epub 2019 Apr 27.
Chamorro A, Lo EH, Renu A, van Leyen K, Lyden PD. The future of neuroprotection in stroke. J Neurol Neurosurg Psychiatry. 2021 Feb;92(2):129-135. doi: 10.1136/jnnp-2020-324283. Epub 2020 Nov 4.
Li J, Zhang L, Xu C, Shen YY, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Chen R, Zhang ZP, Luo CX, Li F, Zhu DY. A pain killer without analgesic tolerance designed by co-targeting PSD-95-nNOS interaction and alpha2-containning GABAARs. Theranostics. 2021 Apr 3;11(12):5970-5985. doi: 10.7150/thno.58364. eCollection 2021.
Li J, Zhang L, Xu C, Lin YH, Zhang Y, Wu HY, Chang L, Zhang YD, Luo CX, Li F, Zhu DY. Prolonged Use of NMDAR Antagonist Develops Analgesic Tolerance in Neuropathic Pain via Nitric Oxide Reduction-Induced GABAergic Disinhibition. Neurotherapeutics. 2020 Jul;17(3):1016-1030. doi: 10.1007/s13311-020-00883-w.
Kaur H, Prakash A, Medhi B. Drug therapy in stroke: from preclinical to clinical studies. Pharmacology. 2013;92(5-6):324-34. doi: 10.1159/000356320. Epub 2013 Dec 12.
Fisher M; Stroke Therapy Academic Industry Roundtable. Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003 Jun;34(6):1539-46. doi: 10.1161/01.STR.0000072983.64326.53. Epub 2003 May 15.
Hackett ML, Kohler S, O'Brien JT, Mead GE. Neuropsychiatric outcomes of stroke. Lancet Neurol. 2014 May;13(5):525-34. doi: 10.1016/S1474-4422(14)70016-X. Epub 2014 Mar 28.
Ferro JM, Caeiro L, Figueira ML. Neuropsychiatric sequelae of stroke. Nat Rev Neurol. 2016 May;12(5):269-80. doi: 10.1038/nrneurol.2016.46. Epub 2016 Apr 11.
Murrough JW, Abdallah CG, Mathew SJ. Targeting glutamate signalling in depression: progress and prospects. Nat Rev Drug Discov. 2017 Jul;16(7):472-486. doi: 10.1038/nrd.2017.16. Epub 2017 Mar 17.
Luscher B, Shen Q, Sahir N. The GABAergic deficit hypothesis of major depressive disorder. Mol Psychiatry. 2011 Apr;16(4):383-406. doi: 10.1038/mp.2010.120. Epub 2010 Nov 16.
Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.
Griebel G, Holmes A. 50 years of hurdles and hope in anxiolytic drug discovery. Nat Rev Drug Discov. 2013 Sep;12(9):667-87. doi: 10.1038/nrd4075.
Shabel SJ, Proulx CD, Piriz J, Malinow R. Mood regulation. GABA/glutamate co-release controls habenula output and is modified by antidepressant treatment. Science. 2014 Sep 19;345(6203):1494-8. doi: 10.1126/science.1250469. Epub 2014 Sep 18.
Li YF. A hypothesis of monoamine (5-HT) - Glutamate/GABA long neural circuit: Aiming for fast-onset antidepressant discovery. Pharmacol Ther. 2020 Apr;208:107494. doi: 10.1016/j.pharmthera.2020.107494. Epub 2020 Jan 25.
Gould TD, Zarate CA Jr, Thompson SM. Molecular Pharmacology and Neurobiology of Rapid-Acting Antidepressants. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:213-236. doi: 10.1146/annurev-pharmtox-010617-052811. Epub 2018 Oct 8.
Zhou L, Li F, Xu HB, Luo CX, Wu HY, Zhu MM, Lu W, Ji X, Zhou QG, Zhu DY. Treatment of cerebral ischemia by disrupting ischemia-induced interaction of nNOS with PSD-95. Nat Med. 2010 Dec;16(12):1439-43. doi: 10.1038/nm.2245. Epub 2010 Nov 21.
Luo CX, Lin YH, Qian XD, Tang Y, Zhou HH, Jin X, Ni HY, Zhang FY, Qin C, Li F, Zhang Y, Wu HY, Chang L, Zhu DY. Interaction of nNOS with PSD-95 negatively controls regenerative repair after stroke. J Neurosci. 2014 Oct 1;34(40):13535-48. doi: 10.1523/JNEUROSCI.1305-14.2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Y-3-LC-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.