Stroke
Conditions
Interventions
Phase I
Group I (experimental) NeuroEPO 0.5 mg every 8 hours for 4 days (intranasal)
Group II (experimental) NeuroEPO 1mg every 8 hours for 4 days (intranasal)
Group III (control ) Placebo 1mL every
Sponsors
Center of Molecular Immunology, CIMAB
Center for investigation and development of medications (CIDEM)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Both sex 2. Age between 18 and 80 years 3. NIHSS between 5 and 20 4. Score between 0 and 1 in the consciousness subscore of NIHSS 5. Upper airway permeable 6. Time between the onset of symptoms and treatment must be lower than 8 hours. Estimated from the information supplied by the patient or its relative: -If onset during sleep, the time of going bed will be taken. -If the patient can not communicate, the last time when the patient was seen well will be taken 7. Informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of observable initial CT hyperdense lesion, whether by intraparenchymatous hemorrhage or cerebral infarction with hemorrhagic transformation 2. Isolated Neurological defects such as: ataxia, loss of sensation, dysarthria, or minimal muscle weakness. 3. Patients with symptoms or neurological signs that back to normal before the start of treatment. 4. Suspicion of inflammatory vascular diseases as a cause of the current Ischemic Brain Infarction (IBI) (lupus and other collagen diseases). 5. Trauma of skull or intracranial surgery recent (less than 4 weeks). 6. Known coagulation disorders. 7. Severe and uncontrolled arterial hypertension (diastolic >110 mm Hg or systolic >220) who does not descend after treatment. 8. Patients where proven coexistence of another disease or process that may lead to significant disability (cancer, septic embolism, endocarditis, malignant hypertension , Myeloproliferative disease, Creatinine >3 mg/dl, Hyperkalaemia > 5.0 mmol/L) 9. Patients with a history of hypersensitivity to the EPO-hr. 10. Pregnant or breastfeeding women. 11. Patients with a known allergy to any of the active substances that make up the product. 12. Patients presenting with nasal irritation (sneezing) or nasal discharge before starting treatment. 13. Patients who have asthma at the time of the initiation of treatment. 14. Patients who are receiving treatment with rTPA. 15. Signs of dysfunction of the brainstem. 16. Patients with severe liver disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seriousness of Advese Events (Serious/No serious). Time of measurement: Daily during Admission, 1 month, 3 months Neurological recovery (Recovered/Non recovered). Time of measurement: 7 days, 1 month, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of Adverse Event-AE (description of the adverse event presented). Measuring time: Daily during Admission, 1 month, 3 months Intensity of the AE (1 Light, 2. Moderate, 3.Severe). Measuring time: Daily during Admission, 1 month, 3 months Causality relationship (1.Very likely/sure, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluable/not classifiable). Measuring time: Daily during Admission, 1 month, 3 months Local tolerance (physical examination). Measuring time: Daily during Admission, 1 month, 3 months Hemoglobin (g/l). Measuring time: Daily during the first 4 days, 1month, 3 months Hematocrit (%). Measuring time: Daily during the first 4 days, 1month, 3 months Platelet count (mm3).Measuring time: Daily during the first 4 days, 1 month, 3 months Partial thromboplastin time (seg).Measuring time: Daily during the first 4 days, 1 month, 3 months Prothrombin time (seg).Measuring time:D aily during the first 4 days, 1month, 3 months Glucose (mmol/L).Measuring time: Daily during the first 4 days, 1month, 3 months Creatinine (umol/L).Measuring time: Daily during the first 4 days, 1month, 3 months Urea:(mmol/L).Measuring time: Daily during the first 4 days, 1month, 3 months Transaminase (TGP) (U/L). Measuring time: Daily during the first 4 days, 1month, 3 months Transaminase (TGO) (U/L). Measuring time: Daily during the first 4 days, 1month, 3 months Sodium (mEq/L). Measuring time: Daily during the first 4 days, 1month, 3 months Potassium (mEq/L). Measuring time: Daily during the first 4 days, 1month, 3 months Post stroke disability (no symptoms, with symptoms but no significant disability, mild disability, moderate disability, disability between moderate and severe, severe disability). Measuring time: Admission, 7 days, 1month, 3months Quality of life (ECVI-38v.3). Measuring time: Admission, 7 days, 1month, 3months Cognitive functioning (Minimental examination). Measuring time: Admission, 7 days, 1month, 3months Depression (Depression scale). Measuri | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
Center of Molecular Immunology (CIM/CIMAB)
Outcome results
None listed