Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-01-08 @ 3:41 PM
Study NCT ID:
NCT01996761
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C006952', 'term': 'cerebrolysin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the improvement ratio of Fugl-Meyer assessment', 'timeFrame': 'after 3 weeks', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Cerebrolysin']}, 'referencesModule': {'references': [{'pmid': '26934986', 'type': 'DERIVED', 'citation': 'Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016 Mar 2;16:31. doi: 10.1186/s12883-016-0553-z.'}]}, 'descriptionModule': {'briefSummary': 'This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 1st cortical or subcortical unilateral infarction (supratentorial lesion)\n2. Confirmed by CT or MRI\n3. Subacute stage: less than 1 week\n4. Moderate to severe motor function involvement-total of FMA: 0-84\n5. Age: between 18 and 80 years\n6. Inpatients\n\nExclusion Criteria:\n\n1. Progressive or unstable stroke\n2. Pre-existing and active major neurological disease\n3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia\n4. A history of significant alcohol or drug abuse in the prior 3 years\n5. Advanced liver, kidney, cardiac, or pulmonary disease\n6. A terminal medical diagnosis consistent with survival \\< 1 year\n7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale\n8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years\n9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin\n10. Current enrolment in another therapeutic study of stroke or stroke recovery\n11. Total serum bilirubin \\> 4 mg/dL, alkaline phosphatase \\> 250 U/L, SGOT/AST \\> 150 U/L, SGPT/ALT \\> 150 U/L, or creatinine \\> 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.\n12. Previous porcine brain peptide administration history'}, 'identificationModule': {'nctId': 'NCT01996761', 'acronym': 'E-COMPASS', 'briefTitle': 'Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke', 'orgStudyIdInfo': {'id': '2010-09-084-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group 1', 'description': 'Study Group 1: 30ml Cerebrolysin', 'interventionNames': ['Drug: porcine brain peptide (Cerebrolysin)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Study Group 2', 'description': 'Study Group 2: Placebo (0.9% NaCl)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'porcine brain peptide (Cerebrolysin)', 'type': 'DRUG', 'armGroupLabels': ['Study Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Study Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yun-Hee Kim', 'investigatorFullName': 'Yun-Hee Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}