Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT01010802
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2009-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Erythropoietin (EPO) in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2009-11-08', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety assessment measured by the absence of adverse events', 'timeFrame': 'weeks 1 to 5, 6, 12, 23 and 35'}], 'secondaryOutcomes': [{'measure': 'Post-treatment change in the motor score of the Unified Assessment Scale for Parkinson Disease´s (UPDRS) in the "OFF" condition as compared with the baseline.', 'timeFrame': 'week 6, 12, 23 and 35'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuroprotection', 'Parkinson Disease', 'Erythropoietin'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '22334107', 'type': 'RESULT', 'citation': "Pedroso I, Bringas ML, Aguiar A, Morales L, Alvarez M, Valdes PA, Alvarez L. Use of Cuban recombinant human erythropoietin in Parkinson's disease treatment. MEDICC Rev. 2012 Jan;14(1):11-7. doi: 10.37757/MR2012V14.N1.4."}, {'pmid': '29862060', 'type': 'RESULT', 'citation': "Pedroso I, Garcia M, Casabona E, Morales L, Bringas ML, Perez L, Rodriguez T, Sosa I, Ricardo Y, Padron A, Amaro D. Protective Activity of Erythropoyetine in the Cognition of Patients with Parkinson's Disease. Behav Sci (Basel). 2018 May 21;8(5):51. doi: 10.3390/bs8050051. eCollection 2018 May."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.", 'detailedDescription': "After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. At present, the treatment of PD with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear.\n\nFor this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO).\n\nPositive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by PD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hohen and Yahr´s Scale between I and III\n* One or more years of evolution of PD,\n* Good response to levodopa (more that 30 % of change)valued in motor UPDRS\n* An acceptable general health status,\n\nExclusion Criteria:\n\n* Chronic psychiatric or other neurological diseases.\n* Previous polyglobulin\n* Hematocryte, same or inferior to 50'}, 'identificationModule': {'nctId': 'NCT01010802', 'briefTitle': "Safety Study of Erythropoietin (EPO) in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'International Center for Neurological Restoration, Cuba'}, 'officialTitle': "Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)", 'orgStudyIdInfo': {'id': 'EPO-001-PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin', 'description': 'There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO) which is a well-known cytokine as a hematopoietic growth factor, so, it is therefore important to control tissular oxygenation. It is considered that EPO protects the neurons by a combination of several mechanisms.\n\nEPOrh is used with high effectiveness in the treatment of anemias with deficiency of erythropoietin.', 'interventionNames': ['Drug: Erythropoietin human recombinant (EPOrh)']}], 'interventions': [{'name': 'Erythropoietin human recombinant (EPOrh)', 'type': 'DRUG', 'otherNames': ['EPOCIM® (Center of Molecular Immunology, Habana, Cuba)'], 'description': 'Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks', 'armGroupLabels': ['Erythropoietin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Havana', 'country': 'Cuba', 'facility': 'Clinic of Movement Disorders, International Center for Neurological Restoration', 'geoPoint': {'lat': 23.13302, 'lon': -82.38304}}], 'overallOfficials': [{'name': 'Ivonne Pedroso, M.D., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Center for Neurological Restoration'}, {'name': 'Lazaro M Alvarez, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Center for Neurological Restoration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Center for Neurological Restoration, Cuba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro de Immunologia Molecular, Cuba', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Movement Disorders Clinic', 'investigatorFullName': 'Ivonne Pedroso Ibanez', 'investigatorAffiliation': 'International Center for Neurological Restoration, Cuba'}}}}