Clinical trial NCT01010802: Safety Study of Erythropoietin (EPO) in Parkinson's Disease
Official title: Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Neuroprotection
Parkinson Disease
Erythropoietin
Lead sponsor: International Center for Neurological Restoration, Cuba
Sponsor class: OTHER
Collaborators: name: Centro de Immunologia Molecular, Cuba
First posted: 2009-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: safety assessment measured by the absence of adverse events
timeFrame: weeks 1 to 5, 6, 12, 23 and 35
Secondary outcomes:
measure: 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.
timeFrame: week 6, 12, 23 and 35
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: Clinic of Movement Disorders, International Center for Neurological Restoration
Study officials:
affiliation: International Center for Neurological Restoration
name: Ivonne Pedroso, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: International Center for Neurological Restoration
name: Lazaro M Alvarez, M.D.
role: STUDY_DIRECTOR
References:
citation: Pedroso I, Bringas ML, Aguiar A, Morales L, Alvarez M, Valdes PA, Alvarez L. Use of Cuban recombinant human erythropoietin in Parkinson's disease treatment. MEDICC Rev. 2012 Jan;14(1):11-7. doi: 10.37757/MR2012V14.N1.4.
citation: Pedroso I, Garcia M, Casabona E, Morales L, Bringas ML, Perez L, Rodriguez T, Sosa I, Ricardo Y, Padron A, Amaro D. Protective Activity of Erythropoyetine in the Cognition of Patients with Parkinson's Disease. Behav Sci (Basel). 2018 May 21;8(5):51. doi: 10.3390/bs8050051. eCollection 2018 May.