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| Name | Class |
|---|---|
| Ever Neuro Pharma GmbH | INDUSTRY |
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This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with severe motor involvement randomized to administration of Cerebrolysin combined with rehabilitation for 3 weeks show better outcome on global function (Korean version Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.
Randomized double-blinded, placebo-controlled multicenter study with two treatment groups
Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this study.
Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrolysin | Experimental | Cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90. |
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| Placebo | Placebo Comparator | Saline 100 ml/day * 21 days with rehabilitation
Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrolysin | Drug | Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation |
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| Measure | Description | Time Frame |
|---|---|---|
| Score of Fugl-Meyer assessment (FMA) | Motor function | 3 months after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Korean version Modified Barthel Index (K-MBI) | Global function | 3 months after stroke |
| Score of National Institute of Health Stroke Scale (NIHSS) | Severity of stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun-Hee Kim, MD, PhD | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C006952 | cerebrolysin |
| C076910 | brain natriuretic peptide, porcine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | Placebo- saline 100 ml/day * 21 days with rehabilitation |
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| 3 months after stroke |
| Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA) | Cognitive function | 3 months after stroke |
| Score of Action Research Arm Test (ARAT) and box and block test | Upper limb function | 3 months after stroke |
| Score of EuroQol (EQ-5D) | Quality of life | 3 months after stroke |
| Days of Length of hospital stay | 3 months after stroke |
| Brain activation of resting-state functional MRI | Neuroplasticity measure | 3 months after stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017670 |
| Sodium Compounds |