Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke

NCT07279493
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
300
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Lead sponsor
Kunming Pharmaceuticals, Inc.
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Start date
2025-11-22
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Number of sites
23
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Summary
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.
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Acronym
KPCXM18
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Short title
Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke
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Official title
A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase Ⅱb Clinical Trial to Evaluate the Efficacy and Safety of the KPCXM18 Injection at Different Doses in The Treatment of Acute Ischemic Stroke
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-10-18
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First posted
2025-12-12
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Registry last updated
2025-12-12
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Primary completion date
2026-10-18
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Start date
2025-11-22
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Randomisation ratio
1:1:1
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Number of sites
23
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Kunming Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07279493
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07279493
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Modified Rankin Scale (mRS), with scores of 0-1 at Day 90

    Timeframe: day 90

    Proportion of subjects with mRS score ≤ 1 at day 90 after administration

  1. Modified Rankin Scale (mRS), with scores of 0-1 at day 12±2 and 30

    Timeframe: days 12±2 and 30

    Proportion of subjects with mRS score ≤ 1 at day 12±2 and 30 after administration

  2. Modified Rankin Scale (mRS), with scores of 0-2 at days 12±2, 30 and 90

    Timeframe: days 12±2, 30 and 90

    Proportion of subjects with mRS score ≤ 2 at day 12±2, 30, 90 after administration

  3. MRS Shift analysis

    Timeframe: day 90

    MRS shift analysis at day 90 after administration

  4. National Institute of Health stroke scale (NIHSS) on day 12±2

    Timeframe: days 12±2

    Proportion of subjects with NIHSS score ≤ 1 or with ≥4 point reduction from baseline at day 12±2 after administration

  5. National Institute of Health stroke scale (NIHSS) on day 12±2

    Timeframe: days 12±2

    Change in NIHSS score from baseline at day 12±2 after administration

  6. Barthel index (BI) at Day 90

    Timeframe: days 90

    Proportion of subjects with BI score ≥95 at day 90 after administration

  7. Barthel index (BI) at Day 90

    Timeframe: days 90

    Proportion of subjects with BI score ≥75 at day 90 after administration

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • 1. Age 18 to 80 years old (including 18 years old and 80 years old, based on the date of signing the informed consent form), male or female;
  • 2.Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 ";
  • 3.During the screening process, it is required that the ischemic stroke should occur within 12 hours after the onset, and it is expected that the investigational drug can be started within 12 hours after the onset; note: The onset time is calculated from the time when the ischemic stroke symptoms appear, If the onset occurs during sleep, the time of onset should be considered as the last time the patient was observed to be normal;
  • 4.Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points;
  • 5.The patients who first attacked, or the patients who had a good prognosis after the last attacked , (mRS score was ≤1 before the onset of the disease );
  • 6.The subject has received or plans to receive standard intravenous thrombolysis treatment after this onset;
  • 7.The subject can understand and follow the research process and voluntarily signs the research informed consent form (the informed consent form is signed by the subject or the legal representative).

  • 1. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc;
  • 2. Patients who have received or plan to receive endovascular interventional treatment (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting) or patients with arteriovenous bridging therapy after this onset;
  • 3. Patients with disturbance of consciousness (NIHSS score Ia>1 point);
  • 4. Patient has a history of intracranial hemorrhage before;
  • 5. Patient who have a history of epilepsy or who experienced epileptic symptoms during a stroke;
  • 6. The patient with other mental illness (such as severe mental disorders, dementia) and combined conditions such as limb movement disorders may influence their neurological function tests;
  • 7. Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month;
  • 8. Patients with malignant tumors, serious diseases of blood, digestion or other systems or diseases with bleeding tendencies (such as hemophilia, etc.), and the expected survival time is not more than 3 months;
  • 9. Despite active antihypertensive therapy, hypertension remains uncontrolled: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg;
  • 10.Patients with severe liver function impairment, or ALT, AST > 2.0× ULN;
  • 11.Patients with severe renal impairment, or serum creatinine > 1.5× ULN;
  • 12.Patients who have used neuroprotective drugs (including Edaravone, Edaravone Dexborneol, Butylphthalide, Piracetam, Urinary Kallidinogenase, Ginkgolide, Ginkgo Diterpene Lactone, Safflower Extract and Aceglutamide Injection, etc.) after the onset of this illness;
  • 13.Patients with severe allergies, hypersensitivity to at least two or more types of drugs, or known to be allergic to any ingredient or excipient of the investigational drug;
  • 14.Patients with a history of major surgery within 1 month before screening;
  • 15.Patients with a history of drug abuse within 3 month before screening;
  • 16.Patients who participated in or are currently participating in other clinical trials within 3 month prior to this study;
  • 17.Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception;
  • 18.The investigator considers that patients are not suitable for clinical trials.
Sources for eligibility
clinicaltrials.gov

  • Beijing Tiantan Hosptial，Capital Medical UniversityBeijing, ChinaRecruiting
  • Shenzhen Second People's HospitalShenzhen, ChinaRecruiting
  • Cangzhou Central HospitalCangzhou, ChinaRecruiting
  • Hengshui People's HospitalHengshui, ChinaRecruiting
  • Da Qing Long Nan HospitalDaqing, ChinaRecruiting
  • Daqing Oilfield General HospitalDaqing, ChinaRecruiting
  • The People's Hospital Of Anyang CityAnyang, ChinaRecruiting
  • Nanshi Hospital Of NanyangNanyang, ChinaRecruiting
  • Nanyang Second General HospitalNanyang, ChinaRecruiting
  • The First Affiliated Hospital Of Nanyang Medical CollegeNanyang, ChinaRecruiting
  • Xuzhou Central HospitalXuzhou, ChinaRecruiting
  • Meihakou Central HospitalMeihekou, ChinaRecruiting
  • Affiliated Central Hospital Of Shenyang Medical CollegeShenyang, ChinaRecruiting
  • The First People's Hospital Of ShenyangShenyang, ChinaRecruiting
  • The People's Hospital Of Liaoning ProvinceShenyang, ChinaRecruiting
  • Yan'an University Xianyang HospitalXianyang, ChinaRecruiting
  • First People's Hospital Of TanchengLinyi, ChinaRecruiting
  • Linyi People's HospitalLinyi, ChinaRecruiting
  • Tengzhou Central People's HospitalTengzhou, ChinaRecruiting
  • Sinopharm Tongmei General HospitalDatong, ChinaRecruiting
  • Linfen Central HospitalLinfen, ChinaRecruiting
  • Linfen People's HospitalLinfen, ChinaRecruiting
  • Jiaxing Second HospitalJiaxing, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • kyjtcrc
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)