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

This study has been completed.
Sponsor:
Information provided by:
International Center for Neurological Restoration, Cuba
ClinicalTrials.gov Identifier:
NCT01010802
First received: November 8, 2009
Last updated: November 9, 2009
Last verified: November 2009
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 8, 2009
Last Updated: November 9, 2009
Health Authority: Cuba: Ministry of Public Health
Cuba: Scientific and Ethics Committee

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

ClinicalTrials.gov processed this record on September 27, 2016