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Study of the KPCXM18 Injection for Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
The KPCXM18 injection
Placebo
Sponsored by
Kunming Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 80 years old (including 18 years old and 80 years old), male or female; Diagnosed with acute ischemic stroke according to the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018"; The time from the last normal behavior to the time of initiation of the drug infusion ≤ 48 hours. For stroke after waking up or when the time of symptom onset cannot be accurately obtained due to aphasia, consciousness disorder, and other reasons, the time of onset should take the last time the patient showed normally as standard; 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 ); During the screening period, 4 points ≤ NIHSS score ≤ 24 points, and the sum of NIHSS fifth upper limb and sixth lower limb score ≥2 points; The subject or his guardian is aware of the study, and if the subject or his guardian is unable to read, the impartial witness reads the informed consent form and other written materials, witnesses the informed consent, voluntarily participates and signs the written informed consent. Exclusion Criteria: Patients with intracranial hemorrhagic diseases confirmed by head CT or MRI: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; Patients with disturbance of consciousness (NIHSS score Ia ≥2 points); Patients who need or have undergone intravenous thrombolysis or endovascular interventional therapy (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting, etc.) or patients with arteriovenous bridging therapy after this onset; 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; Patients with a history of major surgery within 1 month before screening; Patients with severe hypertension (systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥110 mmHg) that cannot be controlled after treatment; Patients with heart rate < 40 beats/min and/or ventricular rate > 120 beats/min; Patients with 2nd and 3rd degree heart blocks without pacemakers or other malignant arrhythmias; Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month; Patients with severe liver function impairment, or ALT, AST > 2.0 times the upper limit of normal value (ULN); Patients with severe renal impairment, or serum creatinine (Cr) > 1.5× ULN; Patients who have used neuroprotective drugs (including commercially available edaravone, edaravone and dexborneol, nimodipine, gangliosides, piracetam, oxiracetam, butylphthalide, etc.) after the onset of this illness, as well as other traditional Chinese medicine labels containing the effect of treating acute ischemic stroke (cerebral infarction); Patients with other psychiatric diseases and limb disorders, including severe mental disorders, dementia and other combined diseases that may affect neurological function tests; Patients with a history of alcohol or drug abuse; Patients with allergies, hypersensitivity to citicoline, KPCXM18 or excipients; Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception; Patients who participated in or are currently participating in other clinical trials within 1 month prior to this study; The investigator considers that patients are not suitable for clinical trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    low-dose group (The KPCXM18 injection)

    middle-dose group (The KPCXM18 injection)

    high-dose group (The KPCXM18 injection)

    Placebo

    Arm Description

    Intravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days.

    Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days.

    Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days.

    Intravenous infusion twice a day with an interval of 12±2 hours for 10 days.

    Outcomes

    Primary Outcome Measures

    Change in NIHSS score from baseline at day 10 after administration
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.

    Secondary Outcome Measures

    Proportion of subjects with mRS score ≤ 1 at day 90±7 after administration
    The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
    Change in BI score from baseline at day 90±7 after administration
    The Barthel Index score ranges from 0 to 100, the higher scores mean a better outcome.
    Change in EQ-5D score from baseline at day 90±7 after administration
    Changes in NIHSS score from baseline on days 30±3 and 90±7 after administration
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
    Changes in mRS score from baseline on days 30±3 and 90±7 after administration
    The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
    The proportion of subjects whose NIHSS score improved by ≥4 points at days 10, 30±3 and 90±7 after administration
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
    Proportion of subjects with recurrence of stroke within 90±7 days after administration
    Changes in serum biomarkers (TNF-α, MMP9, CHE, IL-10, S100-β) from baseline on day 7 after administration

    Full Information

    First Posted
    February 16, 2023
    Last Updated
    February 26, 2023
    Sponsor
    Kunming Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05745311
    Brief Title
    Study of the KPCXM18 Injection for Treatment of Acute Ischemic Stroke
    Official Title
    A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    July 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kunming Pharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 and its PK/PD characteristics in patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke
    Keywords
    stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    low-dose group (The KPCXM18 injection)
    Arm Type
    Experimental
    Arm Description
    Intravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days.
    Arm Title
    middle-dose group (The KPCXM18 injection)
    Arm Type
    Experimental
    Arm Description
    Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days.
    Arm Title
    high-dose group (The KPCXM18 injection)
    Arm Type
    Experimental
    Arm Description
    Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Intravenous infusion twice a day with an interval of 12±2 hours for 10 days.
    Intervention Type
    Drug
    Intervention Name(s)
    The KPCXM18 injection
    Intervention Description
    Intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Intravenous infusion
    Primary Outcome Measure Information:
    Title
    Change in NIHSS score from baseline at day 10 after administration
    Description
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
    Time Frame
    day 10
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects with mRS score ≤ 1 at day 90±7 after administration
    Description
    The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
    Time Frame
    day 90±7
    Title
    Change in BI score from baseline at day 90±7 after administration
    Description
    The Barthel Index score ranges from 0 to 100, the higher scores mean a better outcome.
    Time Frame
    day 90±7
    Title
    Change in EQ-5D score from baseline at day 90±7 after administration
    Time Frame
    day 90±7
    Title
    Changes in NIHSS score from baseline on days 30±3 and 90±7 after administration
    Description
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
    Time Frame
    days 30±3 and 90±7
    Title
    Changes in mRS score from baseline on days 30±3 and 90±7 after administration
    Description
    The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
    Time Frame
    days 30±3 and 90±7
    Title
    The proportion of subjects whose NIHSS score improved by ≥4 points at days 10, 30±3 and 90±7 after administration
    Description
    The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
    Time Frame
    days 10, 30±3 and 90±7
    Title
    Proportion of subjects with recurrence of stroke within 90±7 days after administration
    Time Frame
    within 90±7 days
    Title
    Changes in serum biomarkers (TNF-α, MMP9, CHE, IL-10, S100-β) from baseline on day 7 after administration
    Time Frame
    day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 80 years old (including 18 years old and 80 years old), male or female; Diagnosed with acute ischemic stroke according to the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018"; The time from the last normal behavior to the time of initiation of the drug infusion ≤ 48 hours. For stroke after waking up or when the time of symptom onset cannot be accurately obtained due to aphasia, consciousness disorder, and other reasons, the time of onset should take the last time the patient showed normally as standard; 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 ); During the screening period, 4 points ≤ NIHSS score ≤ 24 points, and the sum of NIHSS fifth upper limb and sixth lower limb score ≥2 points; The subject or his guardian is aware of the study, and if the subject or his guardian is unable to read, the impartial witness reads the informed consent form and other written materials, witnesses the informed consent, voluntarily participates and signs the written informed consent. Exclusion Criteria: Patients with intracranial hemorrhagic diseases confirmed by head CT or MRI: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; Patients with disturbance of consciousness (NIHSS score Ia ≥2 points); Patients who need or have undergone intravenous thrombolysis or endovascular interventional therapy (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting, etc.) or patients with arteriovenous bridging therapy after this onset; 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; Patients with a history of major surgery within 1 month before screening; Patients with severe hypertension (systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥110 mmHg) that cannot be controlled after treatment; Patients with heart rate < 40 beats/min and/or ventricular rate > 120 beats/min; Patients with 2nd and 3rd degree heart blocks without pacemakers or other malignant arrhythmias; Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month; Patients with severe liver function impairment, or ALT, AST > 2.0 times the upper limit of normal value (ULN); Patients with severe renal impairment, or serum creatinine (Cr) > 1.5× ULN; Patients who have used neuroprotective drugs (including commercially available edaravone, edaravone and dexborneol, nimodipine, gangliosides, piracetam, oxiracetam, butylphthalide, etc.) after the onset of this illness, as well as other traditional Chinese medicine labels containing the effect of treating acute ischemic stroke (cerebral infarction); Patients with other psychiatric diseases and limb disorders, including severe mental disorders, dementia and other combined diseases that may affect neurological function tests; Patients with a history of alcohol or drug abuse; Patients with allergies, hypersensitivity to citicoline, KPCXM18 or excipients; Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception; Patients who participated in or are currently participating in other clinical trials within 1 month prior to this study; The investigator considers that patients are not suitable for clinical trials
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Duo Gao, bachelor
    Phone
    0871-68319868-3052
    Email
    duo.gao@kpc.com.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yongjun Wang, MD
    Organizational Affiliation
    Beijing Tiantan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of the KPCXM18 Injection for Treatment of Acute Ischemic Stroke

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