Safety Study of Erythropoietin (EPO) in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Erythropoietin human recombinant (EPOrh)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hohen and Yahr´s Scale between I and III 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: Chronic psychiatric or other neurological diseases. Previous polyglobulin Hematocryte, same or inferior to 50

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br>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)<br>* Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks<br>* Other names: EPOCIM® (Center of Molecular Immunology, Habana, Cuba);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessment measured by the absence of adverse events |  | weeks 1 to 5, 6, 12, 23 and 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | week 6, 12, 23 and 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroprotection, Parkinson Disease, Erythropoietin