Current treatment strategies in Parkinson's disease have guaranteed improvement in the evolution of patients; however, it has not yet been possible to substantially improve the quality of life, stop the progression of the disease or prevent evolutionary complications; main cause of disability. This work addresses the issue of the tolerance of neuroEPO as a neuroprotectant.
We will design a phase I-II clinical trial, monocentric, randomized, placebo, double-blind clinical trial to evaluate the tolerance of n euroEPO in patients with PD. The hypothesis is that euroEPO in the dose of one bulb with 1mg/ml (25,000UI) weekly for five weeks is well tolerated or safe in patients with PD in stages I and II on the Hoehn and Yarhal scale
if mild adverse events occur. The method that will be tested in a group of Parkinsonian patients consists of intranasally applying a neuroEPO solution in a single weekly dose for five weeks in N10 and a placebo in N10, subsequently evaluating the presence of local or general adverse events as well as the behavior of the response to dopaminergic stimulation.
It is proposed to carry out this study with patients in initial and intermediate stages of PD I-II according to the Hoehn and Yarh scale. The evaluation of the tolerance to the product is foreseen as a primary exit measure. As secondary
output measures the impact on PD.
A record of adverse events in the workbooks of the research subjects will be considered in the design, which will be transcribed in automated databases for statistical analysis and permanent monitoring will be carried out during the execution of the protocol.
For automatic data processing, the statistical package IBM SPSS Statistics V 21 will be used. The expected result is that patients tolerate the intranasal use of n euroEPO, which will be measured through the primary outcome variable, that is, the presence of adverse events related to the molecule under study.
This clinical trial is feasible to carry out since neuroEPO is currently produced at the Molecular Immunology Center of Havana (CIM) and there is interest in exploring new applications of the product in the context of the CIREN-CIM Framework Agreement.