Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial

NCT06429384 | Completed Phase 2

• 1 other identifier: Y-3-LC-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 30

Brief Summary

The objective of this clinical trial was to explore the efficacy and safety of Y-3 injection at different doses in patients with acute ischemic stroke within 48 hours of onset. 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

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .

  The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .

  90th day of treatment

Secondary Outcomes (4)

• Grade analysis of mRS Score on the 90th day of treatment;

  90th day of treatment

• The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;

  90th day of treatment

• Changes in NIH Stroke Scale from baseline on day 10 of treatment;

  10th day of treatment

• Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.

  On the 10th and 30th day of treatment

Other Outcomes (13)

• Montgomery Depression Rating Scale scores on day 10 and day 90 were &lt, respectively; Proportion of patients with scores of 12, ≥12, and ≥22;

  On the 10th and 90th day of treatment

• Hamilton Anxiety Scale scores on day 10 and day 90 were &lt, respectively; Proportion of patients with scores of 7, ≥7, and ≥14.

  On the 10th and 90th day of treatment

• Incidence of adverse events (AE) in each group;

  From the time the subject receives medication to the end of the 90th day of the treatment

Study Arms (4)

Y-3 low-dose group (20 mg/dose, qd)

EXPERIMENTAL

Y-3 injection 20mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.

Drug: Y-3 Injection/Y-3 blank injection

Y-3 medium dose group (40 mg/dose, qd)

EXPERIMENTAL

Y-3 injection 40mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.

Drug: Y-3 Injection/Y-3 blank injection

Y-3 high-dose group (60 mg/dose, qd)

EXPERIMENTAL

Y-3 injection 60mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.

Drug: Y-3 Injection/Y-3 blank injection

Blank control group

PLACEBO COMPARATOR

Y-3 blank injection 10ml was diluted with about 250 ml normal saline, intravenous infusion, qd, and continuous medication for 10 days.

Drug: Y-3 Injection/Y-3 blank injection

Interventions

Y-3 Injection/Y-3 blank injection DRUG

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 high-dose group (60 mg/dose, qd); Y-3 low-dose group (20 mg/dose, qd); Y-3 medium dose group (40 mg/dose, qd)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only those who meet all the following criteria can be included in the group:
• Age ≥ 18 years old and\<81 years old, regardless of gender;
• 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;
• Within 48 hours (including 48 hours) of onset;
• 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);
• Obtain informed consent from the patient or their legal representative voluntarily signed and approved by the ethics committee.

You may not qualify if:

• Those who meet one of the following criteria during filtering cannot be included in the group:
• 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;
• Severe consciousness disorder: The item score of NIHSS's 1a consciousness level is greater than 1 point;
• Transient ischemic attack (TIA);
• After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
• Previously diagnosed patients with severe mental disorders and severe dementia;
• Patients previously diagnosed with depression or anxiety disorder;
• Patients undergoing antidepressant or anti anxiety treatment;
• Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc; Or ALT or AST\>2.0 × ULN;
• Diagnosed with severe active kidney disease or renal insufficiency; Or serum creatinine\>1.5 × ULN;
• 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;
• After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;
• Previously diagnosed with concurrent malignant tumors and undergoing anti-tumor treatment;
• Previously diagnosed with severe systemic diseases, with an estimated survival period of\<90 days;
• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Neurodawn Pharmaceutical Co., Ltd.: collaborator

Study Sites (30)

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, 100000, China

Location

Liuzhou Workers Hospital

Liuchow, Guangxi, 545000, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China

Location

Harrison International Peace Hospital

Hengshui, Hebei, 053000, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163000, China

Location

Daqing People's Hospital

Daqing, Heilongjiang, 163000, China

Location

Nanyang Second People's Hospital

Nanyang, Henan, 473000, China

Location

Nanyang South Stone Hospital

Nanyang, Henan, 473000, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, 473000, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, 014000, China

Location

Inner Mongolia Baotou Steel Hospital

Baotou, Inner Mongolia, 014100, China

Location

Inner Mongolia International Mongolian Medicine Hospital

Hohhot, Inner Mongolia, 010000, China

Location

Huai 'an First People's Hospital

Huai'an, Jiangsu, 223001, China

Location

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

Lianyungang Second People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

Taizhou Second People's Hospital

Taizhou, Jiangsu, 225300, China

Location

Xuzhou Central Hospital (Old Hospital Area)

Xuzhou, Jiangsu, 221000, China

Location

Xuzhou Central Hospital（New compound）

Xuzhou, Jiangsu, 221000, China

Location

Xuzhou First People's Hospital

Xuzhou, Jiangsu, 221000, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Beipiao Central Hospital

Beipiao, Liaoning, 122100, China

Location

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

Location

Chinese People's Liberation Army Northern Theater Command General Hospital

Shenyang, Liaoning, 110000, China

Location

Shenyang First People's Hospital

Shenyang, Liaoning, 110000, China

Location

Shandong Third Hospital

Jinan, Shandong, 250000, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

Location

Tancheng County First People's Hospital

Linyi, Shandong, 276100, China

Location

Tengzhou Central People's Hospital

Tengzhou, Shandong, 277500, China

Location

Dongyang City People's Hospital

Dongyang, Zhejiang, 322100, China

Location

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MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shuya Li

  IRB of Beijing Tiantan Hospital Capital Medical University Beijing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In a double-blind design, the researchers, the researchers involved in the trial effect evaluation, the data managers, the statistical analysts, and the subjects and their relatives or guardians were blind to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 28, 2024
• Study Start: June 4, 2023
• Primary Completion: November 18, 2023
• Study Completion: December 24, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)