NeuroEPO-Stroke. Phase I-II

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Safety and efficacy of NeuroEPO in patients with stroke. Phase I-II

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

24/11/2014

Reference number:

IICRD-EC-153

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Alejandro

Last name:

Pando

Medical Specialty :

Second Degree Specialist in Neurology

Affiliation:

Institute of Neurology and Neurosurgery

Postal address:

29 street and D street, Vedado, Plaza

City:

Havana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-78345564

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Cienfuegos, Gustavo Aldereguía López Hospital. Julio López, MD. First Degree Specialist in Neurology

Research ethics committees:

Institute of Neurology and Neurosurgery (INN), December 23, 2013

Gustavo Aldereguía López Hospital, January 30 , 2014

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/10/2014

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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)

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1-2

Target sample size:

Phase I: 33 , Phase II:194 sample size will be calculated again at the end of phase I

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Second Degree Specialist in Pharmacology

Affiliation:

Center of Molecular Immunology (CIM/CIMAB)

Postal Address:

206 street, 1926, between 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537-2715057

Email :

orestesm@cim.sld.cu [1]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Second Degree Specialist in Pharmacology

Affiliation:

Center of Molecular Immunology (CIM/CIMAB)

Postal Address:

206 Street , No.1926between /19 and 21, Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537-2715057 Ext.131

Email :

orestesm@cim.sld.cu [1]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000185

Date of Registration in Primary Registry:

11/09/2014

Record Verification Date:

2017/05/24

Next update date:

2018/05/24

Link to the spanish version:

Click here [2]