Study of the KPCXM18 Injection for Treatment of Acute Ischemic Stroke

February 26, 2023 updated by: Kunming Pharmaceuticals, Inc.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 80 years old (including 18 years old and 80 years old), male or female;
  2. Diagnosed with acute ischemic stroke according to the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018";
  3. 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;
  4. 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 );
  5. 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;
  6. 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:

  1. Patients with intracranial hemorrhagic diseases confirmed by head CT or MRI: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc;
  2. Patients with disturbance of consciousness (NIHSS score Ia ≥2 points);
  3. 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;
  4. 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;
  5. Patients with a history of major surgery within 1 month before screening;
  6. Patients with severe hypertension (systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥110 mmHg) that cannot be controlled after treatment;
  7. 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;
  8. Patients with severe liver function impairment, or ALT, AST > 2.0 times the upper limit of normal value (ULN);
  9. Patients with severe renal impairment, or serum creatinine (Cr) > 1.5× ULN;
  10. 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);
  11. Patients with other psychiatric diseases and limb disorders, including severe mental disorders, dementia and other combined diseases that may affect neurological function tests;
  12. Patients with a history of alcohol or drug abuse;
  13. Patients with allergies, hypersensitivity to citicoline, KPCXM18 or excipients;
  14. Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception;
  15. Patients who participated in or are currently participating in other clinical trials within 1 month prior to this study;
  16. The investigator considers that patients are not suitable for clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: low-dose group （The KPCXM18 injection）
Intravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days.
Drug: The KPCXM18 injection
Intravenous infusion
Experimental: middle-dose group （The KPCXM18 injection）
Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days.
Drug: The KPCXM18 injection
Intravenous infusion
Experimental: high-dose group （The KPCXM18 injection）
Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days.
Drug: The KPCXM18 injection
Intravenous infusion
Placebo Comparator: Placebo
Intravenous infusion twice a day with an interval of 12±2 hours for 10 days.
Drug: Placebo
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in NIHSS score from baseline at day 10 after administration
Time Frame: day 10
The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in EQ-5D score from baseline at day 90±7 after administration
Time Frame: day 90±7
day 90±7
Proportion of subjects with recurrence of stroke within 90±7 days after administration
Time Frame: within 90±7 days
within 90±7 days
Changes in serum biomarkers (TNF-α, MMP9, CHE, IL-10, S100-β) from baseline on day 7 after administration
Time Frame: day 7
day 7
Proportion of subjects with mRS score ≤ 1 at day 90±7 after administration
Time Frame: day 90±7
The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
day 90±7
Change in BI score from baseline at day 90±7 after administration
Time Frame: day 90±7
The Barthel Index score ranges from 0 to 100, the higher scores mean a better outcome.
day 90±7
Changes in NIHSS score from baseline on days 30±3 and 90±7 after administration
Time Frame: days 30±3 and 90±7
The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
days 30±3 and 90±7
Changes in mRS score from baseline on days 30±3 and 90±7 after administration
Time Frame: days 30±3 and 90±7
The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function.
days 30±3 and 90±7
The proportion of subjects whose NIHSS score improved by ≥4 points at days 10, 30±3 and 90±7 after administration
Time Frame: days 10, 30±3 and 90±7
The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
days 10, 30±3 and 90±7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kunming Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongjun Wang, MD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPCXM18/C201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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