Stroke
Conditions
Interventions
Group A: NeuroEPO 1 mg every 8 hours for 4 days by intranasal route. Each dose will be administered at two times. First applies a volume of 250 µL of NeuroEPO in each nostril and 15 minutes later, rep
Sponsors
Center of Molecular Immunology(CIM)/CIMAB
Drug Research and Development Center (CIDEM)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: .Voluntary nature of the subject through the signing of informed consent. .Aged between 18 and 40 years. .Not be organic or psychological disease according to the interrogation. .Conclude successfully the physical examination.
Exclusion criteria
Exclusion criteria: .Women who are pregnant or are breastfeeding.Will be the participants in the study pregnancy test. .Volunteers with hypersensitivity to the active substance(recombinant human erythropoietin)or to any of the active substances that make up the product. .Volunteers with rhinitis of any kind. .Volunteers with the nasal septum deviation. .Volunteers with mental disorders. .Alcoholic volunteers.Will be considered alcoholics those people with more than a quarter of a bottle of rum consumption or 1 bottle of wine or three beers with one frequency greater than 2 times per week. .Presence of chronic non-communicable diseases como asma, hipertensión, diabetes mellitus o cardiopatía isquémica. .Consumption of any drug in the period between the 15 days prior to the start of the trial or during the trial. .Volunteer who has undergone more surgery during the six months prior to the start of the trial. .Having made a donation of blood during the three months prior to the start of the trial. .Participating in a clinical trial during the six months prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of AE (Serious, Not serious). Measuring time:daily during hospitalization. Day 14 Intensity of the AE (1 Light, 2. Moderate, 3.Severe). Measuring time:daily during hospitalization. Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE). Measuring time:daily during hospitalization. Day 14 - Type of AE (description of the adverse event presented) - Severity of AE (Serious, Not serious) - Intensity of the AE (1 Light, 2. Moderate, 3.Severe) - Conduct (Dose diminishment, temporary interruption of treatment, permanent interruption of treatment) - Result (1.Recovery, 2.Recovery with sequels, 3.Improved, 4.Persistence, 5.Death) - Causality relationship (1.Very likely/insurance, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluable/not classifiable) Local tolerance (nasal mucous).Measuring time:daily during hospitalization. Day 14 - Signs of local toxicity (Yes, No) - Intensity (Mild, Moderate, Severe) - Reversible (Yes, No) Hemoglobin (g/l). Measuring time: at the beginning, day 5 and day 14. Hematocrit (%). Measuring time: at the beginning, day 5 and day 14. Reticulocyte count (%).Measuring time: at the beginning, day 5 and day 14. Count of leukocytes (109/L).Measuring time: at the beginning, day 5 and day 14. Platelet count (mm3).Measuring time: at the beginning, day 5 and day 14. Partial thromboplastin time (seg).Measuring time: at the beginning, day 5 and day 14. Prothrombin time (seg).Measuring time: at the beginning, day 5 and day 14. Glucose (mmol/L).Measuring time: at the beginning, day 5 and day 14. Cholesterol (mmol/L).Measuring time: at the beginning, day 5 and day 14. Creatinine (mol/L).Measuring time: at the beginning, day 5 and day 14. Transaminase (TGP) (U/L). Measuring time: at the beginning, day 5 and day 14. Transaminase (TGO) (U/L). Measuring time: at the beginning, day 5 and day 14. Gamma glutamyl transferase(GGT),) (U/L).Measuring time: at the beginning, day 5 and day 14. | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales,MD.
Center of Molecular Immunology (CIM), CIMAB SA
Outcome results
None listed