Safety Study of Erythropoietin (EPO) in Parkinson's Disease
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| ClinicalTrials.gov Identifier: NCT01010802 |
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Recruitment Status :
Completed
First Posted : November 10, 2009
Last Update Posted : November 10, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Drug: Erythropoietin human recombinant (EPOrh) | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| 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) |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | May 2009 |
| Actual Study Completion Date : | May 2009 |
| Arm | Intervention/treatment |
|---|---|
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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) |
- safety assessment measured by the absence of adverse events [ Time Frame: weeks 1 to 5, 6, 12, 23 and 35 ]
- 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 ]
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| Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Cuba | |
| Clinic of Movement Disorders, International Center for Neurological Restoration | |
| Havana, Cuba | |
| 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 |
| 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 Posted: | November 10, 2009 Key Record Dates |
| Last Update Posted: | November 10, 2009 |
| Last Verified: | November 2009 |
Keywords provided by International Center for Neurological Restoration, Cuba:
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Neuroprotection Parkinson Disease Erythropoietin |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Neurodegenerative Diseases Epoetin Alfa Hematinics |