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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010802
• Other study ID #: EPO-001-PD
• Status: Completed
• Phase: Phase 1
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2019
• Source: International Center for Neurological Restoration, Cuba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Cuba	Clinic of Movement Disorders, International Center for Neurological Restoration	Havana

Sponsors (2)

Lead Sponsor	Collaborator
International Center for Neurological Restoration, Cuba	Centro de Immunologia Molecular, Cuba

Country where clinical trial is conducted

Cuba, 

References & Publications (2)

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. — View Citation

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety assessment measured by the absence of adverse events		weeks 1 to 5, 6, 12, 23 and 35
Secondary	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