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

Information source: International Center for Neurological Restoration, Cuba
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Erythropoietin human recombinant (EPOrh) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: International Center for Neurological Restoration, Cuba

Official(s) and/or principal investigator(s):
Ivonne Pedroso, M.D., M.Sc., Principal Investigator, Affiliation: International Center for Neurological Restoration
Lazaro M Alvarez, M.D., Study Director, Affiliation: International Center for Neurological Restoration

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: safety assessment measured by the absence of adverse events

Secondary outcome: 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.

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.

Eligibility

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Clinic of Movement Disorders, International Center for Neurological Restoration, Havana, Cuba
Additional Information

Starting date: August 2008
Last updated: November 9, 2009

Page last updated: August 20, 2015

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