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Completed

NCT Number: NCT01010802

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinic of Movement Disorders, International Center for Neurological Restoration

Havana, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin human recombinant (EPOrh)

Drug

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)

Primary outcomes

  1. safety assessment measured by the absence of adverse events

    Time frame: weeks 1 to 5, 6, 12, 23 and 35

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

International Center for Neurological Restoration, Cuba

Other

Collaborators

  • Centro de Immunologia Molecular, Cuba

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 10, 2009
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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