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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010802
First Posted: November 10, 2009
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
International Center for Neurological Restoration, Cuba
  Purpose
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 Intervention Phase
Parkinson Disease Drug: Erythropoietin human recombinant (EPOrh) Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by International Center for Neurological Restoration, Cuba:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010802


Locations
Cuba
Clinic of Movement Disorders, International Center for Neurological Restoration
Havana, Cuba
Sponsors and Collaborators
International Center for Neurological Restoration, 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

Responsible Party: Ivonne Pedroso, M.D., M.Sc., Neurologist at the Clinic of Movement Disorders CIREN, International Center for Neurological Restoration, Cuba
ClinicalTrials.gov Identifier: NCT01010802     History of Changes
Other Study ID Numbers: EPO-001-PD
First Submitted: November 8, 2009
First Posted: November 10, 2009
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by 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