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

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Erythropoietin human recombinant (EPOrh)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Erythropoietin; 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); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: International Center for Neurological Restoration, Cuba
• Collaborators: Centro de Immunologia Molecular, Cuba
• Investigators: Principal Investigator: Ivonne Pedroso, M.D., M.Sc., International Center for Neurological Restoration; Study Director: Lazaro M Alvarez, M.D., International Center for Neurological Restoration

Publications and helpful links

General Publications

• Pedroso I, Garcia M, Casabona E, Morales L, Bringas ML, Perez L, Rodriguez T, Sosa I, Ricardo Y, Padron A, Amaro D. Protective Activity of Erythropoyetine in the Cognition of Patients with Parkinson's Disease. Behav Sci (Basel). 2018 May 21;8(5):51. doi: 10.3390/bs8050051. eCollection 2018 May.
• Pedroso I, Bringas ML, Aguiar A, Morales L, Alvarez M, Valdes PA, Alvarez L. Use of Cuban recombinant human erythropoietin in Parkinson's disease treatment. MEDICC Rev. 2012 Jan;14(1):11-7. doi: 10.37757/MR2012V14.N1.4.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 8, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Erythropoietin; Parkinson Disease; Neuroprotection
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Hematinics; Epoetin Alfa
• Other Study ID Numbers: EPO-001-PD