NeuroEPO-Stroke. Phase I-II

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000185
• Date of registration: 11/09/2014
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology, CIMAB
• Public title: NeuroEPO-Stroke. Phase I-II
• Scientific title: Safety and efficacy of NeuroEPO in patients with stroke. Phase I-II
• Date of first enrolment: 01/10/2014
• Target sample size: Phase I: 33 , Phase II:194 sample size will be calculated again at the end of phase I
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000185-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 1-2

Countries of recruitment

Cuba

Contacts

• Name: Orestes Santos Morales
• Affiliation: Center of Molecular Immunology (CIM/CIMAB)

• Name: Orestes Santos Morales
• Affiliation: Center of Molecular Immunology (CIM/CIMAB)

Key inclusion & exclusion 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: 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.


Age minimum: 18 years
Age maximum: 80 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

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 8h for 4 days (intranasal)
Phase II
Group I (experimental) NeuroEPO (best dose of phase I) every 8 hours for 4 days (intranasal)
Group II (control) Placebo 1mL every 8 hours for 4 days (Intranasal)

Primary Outcome(s)

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 Outcome(s)

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). Measuring time: Admission, 7 days, 1month, 3months
Functional State (Barthel Index). Measuring time: Admission, 7 days, 1month, 3months
Temperature (Celsius degrees). Measuring time: Every 4 hours the first 4 days, every 8 hours until hospital discharge
Blood pressure (mm Hg). Measuring time: Every 4 hours during admission, 1 month, 3 months

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Cuban Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Center for investigation and development of medications (CIDEM)