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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010802

Enrollment

Registered

2009-11-10

Start date

2008-08-31

Completion date

2009-05-31

Last updated

2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Neuroprotection, Parkinson Disease, Erythropoietin

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.

Interventions

DRUGErythropoietin human recombinant (EPOrh)

Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
safety assessment measured by the absence of adverse events	weeks 1 to 5, 6, 12, 23 and 35

Secondary

Measure	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

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026