A Phase 1 interventional study of Erythropoietin human recombinant (EPOrh) in Parkinson Disease, sponsored by International Center for Neurological Restoration, Cuba. Completed at 1 site in Cuba. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by International Center for Neurological Restoration, Cuba · Phase 1, Interventional, and Prevention
The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →International Center for Neurological Restoration, Cuba is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
Drug: 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
Also known as: EPOCIM® (Center of Molecular Immunology, Habana, Cuba)
safety assessment measured by the absence of adverse events
Time frame: weeks 1 to 5, 6, 12, 23 and 35
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.
Time frame: week 6, 12, 23 and 35
The record gives a start of Aug 2008, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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International Center for Neurological Restoration, Cuba