2025-522796-28-00撤回2 期
A Multicenter, Prospective, Randomized, Open-label Phase 2b Study, with Blinded Evaluation, Comparing the Combination of Amodiaquine and Potassium Canrenoate with Either Exenatide or Glibenclamide Versus Best Medical Therapy, in Patients with Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.
研究概览
简要总结
To evaluate the safety of the investigational treatment compared to best medical therapy (BMT), on hemorrhagic transformation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 80 years, inclusive, at the time of signing the informed consent.
- •Patient with either no history of depression or treated for depression with a stable combination of antidepressants for at least 8weeks before inclusion in the study.
- •Patient with no known history of dementia.
- •Provision of signed informed consent by the patient or caregiver/legal representative, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- •Expectation that the patient will receive standard physical, occupational, and speech rehabilitation therapies as indicated for post-stroke deficits.
- •Patient or caregivers understand study procedures and are willing to comply with them for the entire length of the study.
- •Confirmed diagnosis of AIS, according to the World Health Organization (WHO) definition, as diagnosed with CT.
- •Radiology-confirmed supratentorial IS; nonlacunar, >15 mm diameter in one direction as depicted in the CT scan.
- •NIHSS score at screening ≥5 and ≤20 points.
- •A maximum of 36 h may elapse from symptoms’ onset to treatment initiation.
- •Pre-stroke (36 hours prior to stroke onset) independent functional status in activities of daily living (ie, patients must have been living without requiring nursing care) based on information provided by the patient or his/her caregivers.
- •Patient not a candidate for thrombolysis with tPA.
- •Patient not a candidate for thrombectomy.
- •A diabetic patient must have been on a stable antidiabetic regimen at least 8 weeks before inclusion in the study.
排除标准
- •Allergy/sensitivity to study drugs or their ingredients.
- •Patient presenting with uncontrolled hypertension, blood glucose level >4 mmol/L, cancer, renal failure (defined as creatinine clearance <90 ml/min), evidence of acute myocardial infarction, acute pancreatitis, or other significant medical condition according to Investigator’s opinion.
- •Mental illness or psychiatric disease making the patient incapable of following/participating in this study, as assessed by the Investigator.
- •a. Alanine transaminase (ALT) [or aspartate transaminase (AST)] >2.0 x upper limit of normal (ULN) b. Total bilirubin >1.5xULN (Participants with Gilbert’s syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is ≤1.5 x ULN) c. Current or chronic history of liver disease.
- •Concurrent treatment with any of the investigational drugs in this study.
- •Participation in other clinical trials within 30 days before randomization, or currently involved in other clinical trials.
- •Signs of intracranial hemorrhage or suspected subarachnoid hemorrhage, as assessed based on CT imaging examination.
- •Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency (previously known or as confirmed at the clinical site).
- •Treatment with medications/agents which are contraindicated based on the SmPCs of the combination IMPs for usage in combination with the study interventions.
- •Current drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
- •Inability or unwillingness of patient or caregiver/legal guardian/representative to give written informed consent.
- •Pregnancy or lactation, at screening.
- •Patient who plans to become pregnant within 6 months, or women in childbearing age with negative pregnancy test but who refuses to accept contraception.
- •Patient unlikely to be available for a 90-day follow-up (eg, life expectancy <3 months).
- •Patients with contraindications with the combination of the drugs being studied.
- •Clinical presentation of a lacunar stroke according to site investigators.
- •Patient suffering from intracranial tumors, severe trauma, encephalitis, subarachnoid hemorrhage, or other brain organic diseases.
结局指标
主要结局
Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.
Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.
次要结局
- Degree of disability based on the mRS score
- • Infarct volume defined as MRI lesion volume on Day 5 • Infarct volume defined as MRI lesion volume on Day 90 • Change in DWI lesion volume from Day 5 to Day 90, based on MRI • Change in PWI lesion volume from Day 5 to Day 90, based on MRI
- Change in recanalization of the occluded vessel based on MR angiography (MRA).
- Percentage of patients with clinically meaningful improvement in NIHSS score (improvement >4 points).
- • Percentage of patients treated with investigational combination therapy on top of BMT and those treated with BMT only, experiencing all-cause on-treatment AEs, analyzed for: o patients that complete the study period, and o patients who discontinue from the study period due to an AE. • Percentage of patients with abnormal clinically significant laboratory test results.
- All-cause mortality.
- • Percentage of patients who developed depression, defined as score >10 on the HAM-D17 • Percentage of patients who developed mild to moderate depression (HAM-D17 score: 14-17), or moderate to severe depression (HAM-D17 score: >17).
- Percentage of change in blood biomarkers.
- • Observed plasma concentration • Minimum observed plasma concentration at steady state conditions
- Correlation of plasma concentrations of the investigational combination treatments with: • The percentage of patients experiencing overall AEs and specific AEs • Degree of disability based on the mRS score • The percentage of patients who developed depression • The percentage of patients with clinically meaningful improvement in NIHSS score • MRI response parameters • Biomarker levels • Treatment compliance
研究者
Georgios Karachalios
Scientific
Genesis Pharma S.A.
研究点 (8)
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