Health TrialsbyHealthPanel

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

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKunming Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • The KPCXM18 injection

    Drug

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

  • Placebo

    Drug

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

  • The KPCXM18 injection

    Drug

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: low-dose group （The KPCXM18 injection）Experimental treatment 1 intervention
Group B: high-dose group （The KPCXM18 injection）Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
day 90

Secondary outcomes

1

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

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

Time frame
days 12±2 and 30
2

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

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

Time frame
days 12±2, 30 and 90
3

MRS Shift analysis

MRS shift analysis at day 90 after administration

Time frame
day 90
4

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

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

Time frame
days 12±2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kunming Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now