Safety Study of Erythropoietin (EPO) in Parkinson's Disease
NCT ID: NCT01010802
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2008-08-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tolerance to NeuroEPO in Parkinson Disease
NCT04110678
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
NCT01711866
Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease
NCT03119636
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
NCT02462603
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
NCT00228150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For 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).
Positive 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Erythropoietin
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.
EPOrh is used with high effectiveness in the treatment of anemias with deficiency of erythropoietin.
Erythropoietin human recombinant (EPOrh)
Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erythropoietin human recombinant (EPOrh)
Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* One or more years of evolution of PD,
* Good response to levodopa (more that 30 % of change)valued in motor UPDRS
* An acceptable general health status,
Exclusion Criteria
* Previous polyglobulin
* Hematocryte, same or inferior to 50
45 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro de Immunologia Molecular, Cuba
INDUSTRY
International Center for Neurological Restoration, Cuba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ivonne Pedroso Ibanez
Head of the Movement Disorders Clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ivonne Pedroso, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
International Center for Neurological Restoration
Lazaro M Alvarez, M.D.
Role: STUDY_DIRECTOR
International Center for Neurological Restoration
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinic of Movement Disorders, International Center for Neurological Restoration
Havana, , Cuba
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPO-001-PD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.