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

• ClinicalTrials.gov Identifier: NCT01010802
• Recruitment Status: Completed
• First Posted: November 10, 2009
• Last Update Posted: October 1, 2019
• Sponsor: International Center for Neurological Restoration, Cuba
• Collaborator: Centro de Immunologia Molecular, Cuba
• Information provided by (Responsible Party): Ivonne Pedroso Ibanez, International Center for Neurological Restoration, Cuba

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: Erythropoietin human recombinant (EPOrh)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
• Study Start Date: August 2008
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. safety assessment measured by the absence of adverse events [ Time Frame: weeks 1 to 5, 6, 12, 23 and 35 ]

Secondary Outcome Measures :

1. 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. [ Time Frame: week 6, 12, 23 and 35 ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Cuba

Clinic of Movement Disorders, International Center for Neurological Restoration

Havana, Cuba

Sponsors and Collaborators

International Center for Neurological Restoration, Cuba

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

More Information

Publications of Results:

Pedroso I, Bringas ML, Aguiar A, Morales L, Alvarez M, Valdés PA, Alvarez L. Use of Cuban recombinant human erythropoietin in Parkinson's disease treatment. MEDICC Rev. 2012 Jan;14(1):11-7.

Pedroso I, Garcia M, Casabona E, Morales L, Bringas ML, Pérez L, Rodríguez T, Sosa I, Ricardo Y, Padrón 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.

• Responsible Party: Ivonne Pedroso Ibanez, Head of the Movement Disorders Clinic, International Center for Neurological Restoration, Cuba
• ClinicalTrials.gov Identifier: NCT01010802
• Other Study ID Numbers: EPO-001-PD
• First Posted: November 10, 2009
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

Keywords provided by Ivonne Pedroso Ibanez, International Center for Neurological Restoration, Cuba:

Neuroprotection; Parkinson Disease; Erythropoietin

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Epoetin Alfa; Hematinics