Safety Study of Erythropoietin (EPO) in Parkinson's Disease
|Parkinson Disease||Drug: Erythropoietin human recombinant (EPOrh)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)|
- 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 ]
|Study Start Date:||August 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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
Other Name: EPOCIM® (Center of Molecular Immunology, Habana, Cuba)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010802
|Clinic of Movement Disorders, International Center for Neurological Restoration|
|Principal Investigator:||Ivonne Pedroso, M.D., M.Sc.||International Center for Neurological Restoration|
|Study Director:||Lazaro M Alvarez, M.D.||International Center for Neurological Restoration|