NCT02581371Unknown4 期
Randomized, Double-blind, Placebo-controlled Study of the Effect of Cerebrolysin® (EVER Neuro Pharma GmbH, Austria) at the Level of Paresis of the Upper Limb When Used in Complex Therapy of Acute Ischemic Stroke
Clinical Institute of the Brain, Russia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall dynamics of the hand function assessed by the Frenchay Arm Test
研究概览
简要总结
The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke.
Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.
详细描述
Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity.
After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions.
The therapy consists of the 3 consecutive periods:
- st - 10 days of daily infusions of Cerebrolysin / placebo;
- nd - 7 days break;
- d - 10 days of daily infusions of Cerebrolysin / placebo.
All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The age of 45 years or older than 75 years;
- •Known intolerance (including allergic reactions) Cerebrolysin, excipients of the investigational medication;
- •Thrombolytic therapy;
- •Signs of a hemorrhagic stroke;
- •Impairment of consciousness (≥ 2 points during the evaluation under item 1A NIHSS);
- •The presence of elements allowing to predict the resolution of neurological symptoms within 24 hours from the first symptoms;
- •Stroke or transient ischemic attack in history;
- •The score on the modified Rankin scale to a stroke more than 0 points;
- •Concomitant therapy or neuroprotective nootropic drugs;
- •New-onset seizures or epilepsy;
- •Planned carotid endarterectomy or other operations for secondary prevention of stroke;
- •Neurological disease or pathology of the neuromuscular system or any other disease that may affect the interpretation of study results;
- •Systemic therapy with biological drugs, including interferon, inductors and/or cytokine/anti-cytokine (e.g., anti-TNF, anti-CD4, IL-10, IL-1, etc.) within 1 month prior to screening;
- •Severe concomitant diseases, including cancer, which, in the opinion of the investigator, may affect the estimated parameters;
- •Uncontrolled hypertension (SBP ≥ 220 mm Hg. CL. and/or DBP ≥ 120 mm Hg. article in repeated measurements at the screening visit);
- •Uncontrolled angina, congestive heart failure or severe arrhythmia;
- •The presence of chronic infection (hepatitis B, C or AIDS) in the active form.
- •Severely impaired renal function or hepatic impairment (total bilirubin no more than 1.5 hvgn, the level of serum creatinine no more than 2.5 hugn and the levels of ALT, AST, GGT is not higher than 2.5 hvgn);
- •Diseases of the blood;
- •Mental illness, severe depression or suicide attempts in history;
- •The a history of drug addiction, alcoholism and abuse of drugs;
- •Contraindications to MRI: metal body, splinters, ferromagnetic implants (pacemakers, automatic dosing of drugs, implanted insulin pumps, artificial anus with a magnetic closure, artificial heart valves with metal elements), steel implants (clamps/clips on blood vessels, artificial joints, metal osteosynthesis devices), hearing AIDS;
- •Participation in any other clinical study within 30 days prior to screening or simultaneous participation in other clinical studies;
- •Pregnancy, breastfeeding or planning a pregnancy;
- •Women and men with preserved reproductive potential who refuse to use effective methods of contraception throughout the study;
- •Life expectancy less than 1 year;
- •Any disease or circumstances that, in the opinion of the investigator, may interfere with the subject participating in the study or in relation to which participation in the study may be dangerous for the subject;
- •Premature withdrowal criteria:
- •The research subject may discontinue participation at any time without giving a reason;
- •The researcher ahead of time to exclude the patient from the study in the following cases;
- •The refusal of the subject from further participation in the study;
- •Failure to comply with the subject rules of participation in the study;
- •The reasons that emerged during the study and threatening the security of the subject, including those associated with taking study medication adverse events;
- •The entities with during the study pregnancy;
- •The application of the patient in the study period of any additional neuroprotective and nootropic drugs, drugs from the group of correctors of cerebral blood flow;
- •Other reasons arising in the course of the study and prevent the realization of the study according to the Protocol;
- •Repeated stroke in the course of the study;
- •Subjects who are lost to observation, also belong to prematurely withdrawn from the study.
研究组 & 干预措施
Cerebrolysin infusion
Experimental
Cerebrolysin, solution for injection, 10 ml vials. Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
干预措施: Cerebrolysin infusion (Drug)
Placebo infusion
Placebo Comparator
Sodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval.
干预措施: Placebo infusion (Other)
结局指标
主要结局
Overall dynamics of the hand function assessed by the Frenchay Arm Test
时间窗: 6 months
Visit 5 data comparison with Visit 0 data
次要结局
- Dynamics of the hand function assessed by the Frenchay Arm Test(6 months)
- Dynamics of the grades on the NIHSS scale(6 months)
- Dynamics of the grades on the modified Rankin scale(6 months)
- Dynamics of the Barthel index changes(6 months)
- Dynamics of the cerebral infarction volume decrease according the 3D MRI data(6 months)
- Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)(6 months)
- Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)(6 months)
- Dynamics of the amplitude of motor responses(6 months)
- Dynamics of the latency of motor responses(6 months)
- Frequency, nature and severity of adverse events.(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
终止
4 期
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and NeurorecoveryTraumatic Brain InjuryNCT01606111Ever Neuro Pharma GmbH46
已完成
2 期
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's DiseaseAlzheimer DiseaseNCT00911807Ever Neuro Pharma GmbH217
招募中
3 期
Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.Stroke, IschemicStroke, AcuteStroke SequelaeNCT04904341Military Institute od Medicine National Research Institute50
已完成
4 期
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in StrokeStrokeNCT02768571Samsung Medical Center80
招募中
2 期
Cerebrolysin in CADASIL2024-513828-42-00Ever Neuro Pharma GmbH30