Acute Ischemic StrokePhase 2NCT05745311
Study of the KPCXM18 Injection for Treatment of Acute Ischemic Stroke
A Phase 2 study testing The KPCXM18 injection in people with Acute Ischemic Stroke, run by Kunming Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- The KPCXM18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- The KPCXM18 injection, Placebo
- Keywords
- stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The KPCXM18 injectionDrug
Intravenous infusion
PlaceboDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| low-dose group （The KPCXM18 injection） | Experimental | Intravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days. Receives: Drug: The KPCXM18 injection |
| middle-dose group （The KPCXM18 injection） | Experimental | Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days. Receives: Drug: The KPCXM18 injection |
| high-dose group （The KPCXM18 injection） | Experimental | Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days. Receives: Drug: The KPCXM18 injection |
| Placebo | Placebo comparator | Intravenous infusion twice a day with an interval of 12±2 hours for 10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 10
Secondary outcomes (8)
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.
Measured: day 90±7
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.
Measured: day 90±7
Change in EQ-5D score from baseline at day 90±7 after administration
Measured: day 90±7
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.
Measured: days 30±3 and 90±7
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.
Measured: 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
The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function.
Measured: days 10, 30±3 and 90±7
Proportion of subjects with recurrence of stroke within 90±7 days after administration
Measured: within 90±7 days
Changes in serum biomarkers (TNF-α, MMP9, CHE, IL-10, S100-β) from baseline on day 7 after administration
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745311
- Sponsor's protocol ID
- KPCXM18/C201
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05745311
- Acronym / sponsor ID
- KPCXM18/C201
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-dose group （The KPCXM18 injection） | Experimental | Drug: The KPCXM18 injectionIntravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days. |
| middle-dose group （The KPCXM18 injection） | Experimental | Drug: The KPCXM18 injectionIntravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days. |
| high-dose group （The KPCXM18 injection） | Experimental | Drug: The KPCXM18 injectionIntravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days. |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous infusion twice a day with an interval of 12±2 hours for 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The KPCXM18 injectionIntravenous infusion | Drug | high-dose group （The KPCXM18 injection）, low-dose group （The KPCXM18 injection）, middle-dose group （The KPCXM18 injection） |
| PlaceboIntravenous infusion | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
Proportion of subjects with mRS score ≤ 1 at day 90±7 after administration
Time frame: day 90±7
Change in BI score from baseline at day 90±7 after administration
Time frame: day 90±7
Change in EQ-5D score from baseline at day 90±7 after administration
Time frame: 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
Changes in mRS score from baseline on days 30±3 and 90±7 after administration
Time frame: 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
Proportion of subjects with recurrence of stroke within 90±7 days after administration
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The KPCXM18 injection in people with Acute Ischemic Stroke, run by Kunming Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duo Gao, bachelor (0871-68319868-3052, duo.gao@kpc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIHSS score from baseline at day 10 after administration (time frame: day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.