Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
Overview
- Phase
- Phase 1
- Intervention
- Erythropoietin human recombinant (EPOrh)
- Conditions
- Parkinson Disease
- Sponsor
- International Center for Neurological Restoration, Cuba
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- safety assessment measured by the absence of adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Ivonne Pedroso Ibanez
Head of the Movement Disorders Clinic
International Center for Neurological Restoration, Cuba
Eligibility 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
Arms & Interventions
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.
Intervention: Erythropoietin human recombinant (EPOrh)
Outcomes
Primary Outcomes
safety assessment measured by the absence of adverse events
Time Frame: weeks 1 to 5, 6, 12, 23 and 35
Secondary Outcomes
- 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)