Tolerance to NeuroEPO in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment strategies in Parkinson's disease (PD) can improve a patient's quality of life but
      cannot stop the progression of PD. The investigators are looking for different alternatives
      that modify the natural course of the disease and recent research has demonstrated the
      neuroprotective properties of erythropoietin. In Cuba, the Center for Molecular Immunology
      (CIM) is a cutting edge scientific center where the recombinant form (EPOrh) and recombinant
      human erythropoietin with low sialic acid (NeuroEPO) are produced.
    

Detailed description: 
      Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through
      intranasal route could benefit patients with neurological disorders. A new nasal formulation
      containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions
      in preclinical models and the safety trial of NeuroEPO was evaluated for the first time in
      humans in Cuba.

      The researchers previously conducted a proof of concept clinical trial, administering EPOrh
      subcutaneously where the neuropsychological performance was measured as a secondary endpoint.
      This protocol has the register number NCT01010802. Results showed an increased
      neuropsychological performance of patients after administration as compared to before
      administration results.

      In this protocol two institutions were leading a physician clinical trial.The two
      institutions: International Center for Neurological Restoration (CIREN from Centro
      Internacional de Restauracion Neurologica from Spanish) where the recruitment and clinical
      evaluation of the PD patients will be done and the Center for Molecular Immunology, who was
      the promoter.

      Randomisation will be performed by the CIM to assign the patients to groups. The groups will
      receive neuroEPO or placebo with identical organoleptic characteristics. The informed consent
      of all patients will be obtained before the start of the trial after the selection and
      primary evaluation of the inclusion criteria.

      The dose of neuroEPO will be a vial with a dose of 1 mL/1mg administered intra-nasally for
      five consecutive weeks. The placebo group was administered 1 mL of an intranasal inert
      solution for the same period of time.

      The IBM SPSS Statistics V 21 package will be used for the statistical analysis of the data.
      The investigators will use tables of frequency analysis and descriptive statistics to analyse
      the demographic characteristics of the sample.

      The analysis of the results obtained will be done studying the differences between
      quantitative variables for paired and unpaired samples, the Wilcoxon and U of Mann-Whitney
      tests will be used respectively. For the qualitative variables Chi square (X2) test will be
      used. All values of p < 0.05 will be considered significant.
    

Intervention name(s): NeuroEPO
Intervention type(s): Drug
Intervention description(s): NeuroEPO [CIMAB S.A, Havana, Cuba]
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, blinded, Physician lead trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease; Tolerance; NeuroEPO; side effects; UPDRS; Cognition