Spinocerebellar Ataxia
Conditions
Interventions
Group I (Experimental): NeuroEPO 1mg (1ml) 3 times per week (alternate days) administered intranasally for 12 months. At first a volume of 0.25 ml will be administered in a nostril, putting pressure o
Erythropoietin
Administration, Intranasal
Placebos
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. otal SARA scale score between 3 and 14 points. 2. Ages between 18 and 70 years (inclusive). 3. Expresses in writing your consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Suffering from decompensated chronic diseases (Cardiopathies, Diabetes Mellitus, Arterial Hypertension, Chronic Renal Failure, Bronchial Asthma, etc.). 2. Parkinson's manifestations and/or frontotemporal dementia. 3. History of any other degenerative or systemic neurological disease with an impact on the nervous system. 4. History of psychiatric illnesses. 5. Known bleeding disorders or active bleeding. 6. Patient who is being treated with anti-aguerants or anticoagulants. 7. Severe acute diseases at the time of inclusion. 8. Pregnant or lactating woman. 9. Patient with reproductive and sexually active capacity who does not agree to use at least one effective method of contraception prior to inclusion in the study and/or during participation in the clinical trial (in the case of the female sex: intrauterine devices, barrier methods, hormones or tubal ligation and in the case of the male sex: vasectomy, condom use). 10. Hypersensitivity to the active substance (recombinant human erythropoietin) or to any of the active substances that make up the product. 11. You are participating in another clinical trial. 12. History of alcoholism and/or pharmacodependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total SARA scale score (total value of the score). Measurement time: in the initial evaluation (baseline) and in the evaluations of month 6 and final (month 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive affective functions (score value obtained after application of the Affective Cognitive Cerebellar Syndrome scale (SCHMAHMANN syndrome). Measurement time: At baseline and, 6 and 12 months. 2. Volume and area of the cerebral cortex (obtained through MRI imaging studies). Measurement time: At baseline and, 6 and 12 months. 3. Volume and area of the cerebellum (obtained through MRI imaging studies). Measurement time: At baseline and, 6 and 12 months. 4. Volume and area of the brain stem (obtained through MRI imaging studies). Measurement time: At baseline and, 6 and 12 months. 5. Adverse Events-AE (Occurrence (yes/no); Type of AE (AE name); Severity of the AE (Severe, Not Serious); Intensity of the AE (Mild, Moderate, Severe); Duration of the AE (Difference of dates between the start and end of the event); Causation Ratio (Very Likely, Probable, Possible, Unlikely, Unrelated, Not evaluable); Attitude to treatment (unchanged, dose modification, temporary interruption, or definitive); Treatment of the AE (treatment received); AE result (recovered, improved, persists or sequels)). Measurement time: During a time patient study until 12 months. 6. Vital signs (Blood pressure (systolic/diastolic), heart rate (FC), respiratory rate (FR)). Measurement time: Before and after each intranasal application. 7. Cardiovascular function (result of the electrocardiogram). Measurement time: At baseline and, 6 and 12 months. 8. Laboratory tests (Hematology [values of hemoglobin, differential leukogram, hematocrit, platelets]; Blood chemistry [values of urea, creatinine, glycemia, glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT)]; Coagulation tests [partial thromboplastin time (PTT), prothrombin time (PT)]). Measurement time: At baseline and, 6 and 12 months. | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
Center of Molecular Immunology
Outcome results
None listed