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

International Center for Neurological Restoration, Cuba

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Erythropoietin human recombinant (EPOrh)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01010802

EPO-001-PD

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Erythropoietin

Experimental group

Description:

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.

Treatment:

Drug: Erythropoietin human recombinant (EPOrh)