A Multicenter, Double-blind, Randomized, Parallel Group Placebo-controlled Clinical Trial of Efficacy and Safety of MMH-MAP in the Treatment of Cognitive Disorders in Patients With Ischemic Stroke in the Carotid Arteries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 22
- 主要终点
- Average MoCA Score.
研究概览
简要总结
The clinical trial to valuate efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
详细描述
Design: double-blind, randomized, parallel group placebo-controlled clinical study of efficacy and safety of MMH-MAP in the treatment of cognitive disorders in patients with ischemic stroke in the carotid arteries.
The study will enroll hospitalized subjects of either gender aged 40-75 years old with verified diagnosis of ischemic stroke in the carotid arteries within 72 hours post debut having moderate cognitive disorders, moderate neurological deficit.
At Visit 1 (day 1) the subject's complaints and medical history will be collected, objective examination, safety laboratory tests (hematology, serum chemistry, urinalysis) will be performed. The investigator will evaluate the patient's level of consciousness using The Glasgow Coma Scale, intensity of cognitive disorders using The Montreal Cognitive Assessment (МоСА), condition using National Institute of Health Stroke Scale (NIHSS) and The Modified Rankin Scale (mRs). Concomitant therapy will be recorded and changes in cerebral CT/MRI will be evaluated. If the subject meets inclusion criteria and has no exclusion criteria, he/she will be randomized to MMH-MAP or Placebo group. The first dose of the study product should be taken within 72 hours post stroke debut.
At Visit 2 (day 12±3, end of hospitalization period - the last day of hospitalization due to the current stroke) complaints will be collected, objective examination findings will be recorded, monitoring of the prescribed and concomitant therapy will be performed, treatment safety, compliance and stroke severity according to NIHSS will be evaluated.
By the end of hospital therapy the subject will be switched to outpatient therapy with continuation of IMP and medical assistance designed for the treatment of stroke and its sequelae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years old inclusively.
- •Ischemic stroke in the carotid arteries (I 63) within 72 hours post debut.
- •Moderate cognitive disorders (MoCA < 26).
- •Normal consciousness (Glasgow score 15)
- •Stroke severity 8-12 according to NIHSS.
- •Disability mRs score 2-
- •Availability of cerebral CT/MRI within 72 hours post stroke debut.
- •Patients who agreed to use a reliable method of contraception during the study.
- •Patients who have signed the Participant Information Sheet and Informed Consent.
排除标准
- •Current or previous subarachnoidal/parenchymatous/ventricular hemorrhage, cerebral infarction, cerebral tumour.
- •Cerebral CT/MRI findings suggesting cerebral hemorrhage, tumour within 72 hours post stroke debut.
- •Scheduled or completed thrombolytic therapy for the treatment of the current cerebral infarction.
- •Central nervous system (CNS) diseases including:
- •Inflammatory diseases of the central nervous system (G00-G09);
- •Systemic atrophies primarily affecting the central nervous system (G10-G13);
- •Extrapyramidal and movement disorders (G20-G26);
- •Other degenerative diseases of the nervous system (G30-G32);
- •Demyelinating diseases of the CNS (G35-G37);
- •Episodic and paroxysmal disorders (G40-G47);
- •Polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders;
- •Hydrocephalus (G91).
- •Head injuries (S00-S09) (including history), accompanied by impaired consciousness, brain contusion or open craniocerebral injuries.
- •Musculoskeletal disorders causing motor disturbances.
- •Dementia (including history) (F00-F03).
- •Malignant neoplasms.
- •Patients previously diagnosed with class IV heart failure (1964 New York Heart Association functional classification), hypothyroidism, or poorly treated diabetes mellitus.
- •Patients having unstable angina or myocardial infarction in the past 6 months.
- •Allergy/ intolerance to any of the components of medications used in the treatment.
- •Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- •Any conditions which, according to the investigator opinion, may interfere with the subject's participation in the study.
- •Prior history of non-adherence to a drug regimen, a psychiatric disorder, alcoholism or drug abuse, which, in the opinion of the investigator, can compromise compliance with study protocol.
- •Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- •Participation in other clinical studies within 3 month prior to enrollment in the study.
- •Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
研究组 & 干预措施
MMH-MAP
Oral administration. 2 tablets twice daily (approximately at the same time). The drug is taken outside a meal (between the meals or 15 min prior to meal or fluid intake). Tablets should be held in the mouth until completely dissolved. The overall duration of treatment is 90 days.
干预措施: MMH-MAP (Drug)
Placebo
Oral administration. For 90 days according to MMH-MAP dosing regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Average MoCA Score.
时间窗: On baseline and on 90th day of the treatment.
Montreal Cognitive Assessment Scale (The Montreal Cognitive Assessment, MoCA) will be used to identify moderate cognitive impairment, as well as to assess changes in cognitive functions during therapy. The maximum possible number of points is 30; 26 points or more is considered normal. The minimum score is 0, higher score is better.
次要结局
- Changes in NIHSS Score.(On baseline, on 12th and on 90th days of the treatment.)
- Percentage of Patients With no Significant Disabilities.(On 90th day of the treatment.)
- Therapeutic and Side Effects, Efficacy Index.(On 90th day of the treatment period.)
- Presence of Adverse Events (AEs).(For 90 days of the treatment period.)
- Percentage of Patients With Complication of Cerebral Infarction.(For 90 days of the treatment period.)
- Death Rate.(For 90 days of the treatment period.)
- Changes in Vital Signs (Pulse Rate (Heart Rate)).(Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).)
- Changes in Vital Signs (Respiration Rate (Breathing Rate)).(Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90))
- Changes in Vital Signs (Blood Pressure).(Visit 1 (day 1), Visit 2 (day 12), and Visit 4 (day 90).)
- Percentage of Patients With Clinically Significant Abnormal Laboratory Data.(On baseline and on 90th day of the treatment.)
- Percentage of Patients With Recurring Cerebral Infarction.(For 90 days of the treatment period.)