Parkinson's disease stage II-III
Conditions
Interventions
Group A (experimental): 0.5 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and, then continue with 1mg weekly for 20 weeks (maintenance period).
Group B (experimental):
Erythropoietin
Administration, Intranasal
Placebos
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with Parkinson's disease, who meet the diagnostic criteria of BBL and stage II-III according to Hoehn and Yahr scale. 2. Patients older than 18 years. 3. One or more years of evolution of motor symptoms. 4. Good response to dopaminergic stimulation. 5. Acceptable general health status, not previous polygllobulia (Hto equal or lower than 50). 6. Patients who consent to participate in the study by signing the informed consent model.
Exclusion criteria
Exclusion criteria: 1. Negative patient to participate in the study. 2. Presence of signs indicative of cognitive deterioration or psychiatric complications at the time of study. 3. Presence of accidents or other diseases during the therapeutic period that disqualify the patient to clinical trial. 4. Patients with known hypersensitivity to any component of the formulation. 5. Patients who are pregnant or breastfeeding. 6. Patients of childbearing potential not using contraceptive methods. 7. Patients with uncontrolled hypertension (systolic pressure mayor 180 mmHg and / or diastolic pressure mayor 120 mmHg). 8. Patients receiving treatment with immunosuppressants, androgens or anabolic steroids in the month prior to inclusion. 9. Patients with haematological diseases: sickle cell, myelodysplastic syndromes, coagulation disorders or active bleeding. 10. Patients with severe hyperparathyroidism. 11. Patients diagnosed with malignant tumor or anticancer therapy. 12. Patients with decompensated psychiatric illness. 13. Patients with alcoholism or drug addiction in the two years prior to the evaluation for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total UPDRS Value (UPDRS scale). Measuring time: 9 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Related to eficacy 1. UPDRS motor. measure by UPDRS III. Measuring time: 0, 6, 9 months 2. Daytime mobility fluctuations: measured by self-report. Measure by: Presence of on/off (on and off) dyskinesias (yes/no), dystonias (score), paradoxical fluctuations (score). Measuring time: 0, 6, 9 months 3. Total dose of dopaminergic stimulation. Measure by percentage. Measuring time: in each administration of the product. 4. Cognitive impairment. Measured by the DRS (Dementia Rating Scale) by Mattis. Measuring time:: 0, 9 months 5. Mental flexibility. Measured by the Trail Test (TMT). Measuring time: 0, 9 months 6. Working Memory. Measured by the TMT. Measuring time: 0, 9 months 7. Motor response rate. Measured by the TMT. Measuring time: 0, 9 months 8. Sustained attention. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months 9. Working memory. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months 10. Phonological verbal fluency. Measured by the Verbal Fluency Test (FAST). Measuring time: 0, 9 months 11. Semantic verbal fluency. Measured by FAST. Measuring time: 0, 9 months 12. Ability to alternate mental categories. Measured by FAST. Measuring time: 0, 9 months 13. Executive function. Measured by Litvan Frontal Assessment Battery (FAB). Measuring time: 0, 9 months 14. Selective attention (Measured by Stroop test). Measuring time:: 0, 9 months 15. Focused attention (Measured by Stroop test). Measuring time: 0, 9 months 16. Visuoconstructive function (Measured by Fig. De Rey). Measuring time: 0, 9 months 17. Visual memory (Measured by Fig. Of Rey). Measuring time:: 0, 9 months 18. Level of anxiety. Measured by the HADS (Hospital Anxiety and Depression Scale) Hospital Anxiety and Depression Scale. Measuring time: 0, 9 months 19. Level of depression. Measured by HADS. Measuring time: 0, 9 months Related to safety: 20. Adverse Events-AE (Severity of AE (serious or not), Type of AE (accordint to Regulation 45/ | — |
Countries
Cuba
Contacts
Public ContactLeslie Perez Ruiz
Center of Molecular Immunology (CIM)
Outcome results
None listed