Trial | NCT01010802  Report issue

Title

Safety Study of Erythropoietin (EPO) in Parkinson's Disease
Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epoetin ...

  • Study Participants

    10
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.
Study Started
Aug 31
2008
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
Oct 01
2019

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 names: EPOCIM® (Center of Molecular Immunology, Habana, Cuba)

Erythropoietin Experimental

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.

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
No Results Posted