NeuroEPO in stroke

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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 Evidence of the Effect of NeuroEPO in patients with Acute CerebRal Infarction. Ph I-II.

Acronym of Scientific Title:

SErONICA

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)

Reference number:

In process

Principal investigator

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

First name:

Luisa

Last name:

Paz Sendin

Medical Specialty :

Second degree specialist in Neurology

Affiliation:

Carlos J. Finlay Hospital

Postal address:

‎Avenue 31 & 114

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72743000

Email address:

luisapazs@infomed.sld.cu

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:

Havana, National Institute of Neurology, MD. Raysa Rodriguez, Second degree specialist in Neurology

Havana, Manuel Fajardo Hospital, MD. Asdrubal Arias , Second degree specialist in Neurology

Cienfuegos, Gustavo Aldereguía Lima Hospital, MD. Joan Rojas, Second degree specialist in Neurology

Havana, Calixto García Hospital, to define

Research ethics committees:

Carlos J. Finlay Hospital, in review

National Institute of Neurology, in review

Manuel Fajardo Hospital, in review

Gustavo Aldereguía Lima, in review

Calixto García, in review

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/03/2019

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

Health condition(s) code:

Stroke

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Vascular Diseases

Cardiovascular Diseases

Health condition keyword:

Ischemic stroke

Intervention(s):

Stage I Group A (Experimental)-NeuroEpo 1mg (13 patients): It will receive 1.0 mg of NeuroEPO by nasal route every 8 hours for 3 days. From the 4th day and up to the 7th 1.0 mg 1 time a day; from the 8th day until the month 3, 0.5mg 3 times a week. Group B (Experimental)-NeuroEpo 0.5mg (13 patients): It will receive 0.5 mg of NeuroEPO by nasal route every 8 hours for 3 days. From the 4th day and up to the 7th 1.0 mg 1 time a day; from the 8th day until the month 3, 0.5mg 3 times a week. Group C (Control)-Placebo (13 patients): It will be divided into 2 parts. One part (7 patients) will receive 1.0 mg of Placebo every 8 hours for 3 days. From the 4th day and up to the 7th 1.0 mg 1 time a day. from the 8th day to the month 3 0.5 mg 3 times a week and the other part (6 patients) will receive 0.5 mg of Placebo every 8 hours for 3 days. From the 4th day and up to the 7th 1.0 mg 1 time a day. from the 8th day to the month 3 0.5 mg 3 times a week. Stage II After 3 months, the Bayes Factor (BF) will be estimated as a Benefit-Risk measure and the group with the highest BF will go to this stage with the scheme that it brings from stage I with the same duration of treatment (3 months). In this scheme will be included the rest of the patients

Intervention code:

Erythropoietin

Neuroprotective Agents

Administration, Intranasal

Placebos

Intervention keyword:

NeuroEPO

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):

1. Serious adverse events with definite causal association, very probable or probable with the administration of the product. Measurement time: in each product administration, 3, 7 days, 1, 3, 6 months. 2. Degree of ICTUS (NIHHS scale). Measurement time: at baseline, 7 days, 1, 3 and 6 months. 3. Functional statu (Barthel index). Measurement time: 3 and 6 months. 4. Degree of disability (Rankin scale). Measurement time: 3 and 6 months.

Key secondary outcomes:

Security variables: 1. Adverse events-AD (Gravity of the AD (severe or not), Type of AD (according to categories of Regulation 45 of 2007 of the CECMED), Intensity of the AD (mild, moderate, severe), Causality of the AD (very probable, probable, possible, improbable, unrelated or non-evaluable), Attitude towards the drug (No change, Dose reduction, Temporary interruption of treatment, Definitive interruption of treatment), Result (Reversible effect, Irreversible effect, Death, Loss of follow-up of the patient)). Measurement time: 3, 7 days, 1, 3 and 6 months and in each administration of the product 2. Blood pressure (mm / hg). Measurement time: The 1st day every 4 hrs. From day 2 to discharge (day 7) cda 8 hrs, evaluation to the month, 3 and 6 months and in each administration of the product 3. Laboratory tests (Hemoglobin (normal, abnormal), Hematocrit (normal, abnormal), Normal platelet count, abnormal), WBC count (normal, abnormal), Prothrombin and thromboplastin (normal, abnormal),TGO (normal, abnormal), TGP (normal, abnormal), Creatinine (normal, abnormal), uric acid (normal, abnormal), sodium (normal, abnormal), potassium (normal, abnormal)). Measurement time: On admission, day 4, month and 3 months Related to efficiency 4. Post-stroke depression (Geriatric Depression Scale. The presence of depression will be defined when the score of the scale is greater than or equal to 10). Measurement time: 3 and 6 months. 5. Post-stroke quality of life (Scale of Quality of Life for Stroke). Measurement time: 3 and 6 months. 6. Cognitive impairment post-stroke (MMSE). Measurement time: 3 and 6 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:

19 years

Maximum age:

None

Inclusion criteria:

1- Patients with ages equal to or greater than 19 years. 2- Patients with a score between 6 and 20 on the neurological scale NIHSS. They must have a score of 0 or 1 in the level of awareness section of said scale. 3- Have permeable airways. 4- Time elapsed between the onset of symptoms and the start of treatment ≤ 24 hours. Calculated from the information provided by the patient or family member: - If the debut occurs during sleep, it will be taken the time you went to sleep. - If you can not communicate, by altering the language or speech, you will take the last hour when you saw it well. 5- Patients and / or relative or legal tutor who grant their consent to participate in the study.

Exclusion criteria:

1- Isolated neurological defects such as: ataxia, loss of sensitivity or minimal muscle weakness. 2-Patients with neurological symptoms or signs that return to normal before the start of treatment. 3-Suspected vascular inflammatory diseases as a cause of current ICTUS (lupus and other collagen diseases). 4-Skull trauma or recent intracranial surgery (less than 4 weeks). 5-Known coagulation disorders. 6-Severe and uncontrolled arterial hypertension (systolic> 220 or diastolic> 110 mm Hg) that does not descend after treatment. 7-Patients where coexistence of another disease or process leading to significant disability is demonstrated (cancer, septic embolism, endocarditis, malignant hypertension, myeloproliferative disease, creatinine> 3 mg / dl, hyperkalemia> 5.0 mmol / L). 8-Patients with a history of hypersensitivity to EPO-hr. 9-Women who are pregnant or breast-feeding. 10-Patients with a known allergy to any of the active substances that make up the product. 11-Patients who present nasal irritation (sneezing) or nasal discharge before starting treatment. 12-Patients who present asthma attacks at the time of treatment initiation. 13-Patients who are receiving rTPA treatment. 14-Signs of brain stem dysfunction. 15-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:

130

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:

Leslie

Last Name:

Perez Ruiz

Specialty:

Bachelor degree in Pharmaceutical Sciences

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Street 216, at corner 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72143202

Email :

leslie@cim.sld.cu

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:

Luisa

Last Name:

Paz Sendin

Specialty:

Second degree specialist in Neurology

Affiliation:

Carlos J. Finlay Hospital

Postal Address:

Ave 31 y 114

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72743000

Email :

luisapazs@infomed.sld.cu

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:

RPCEC00000282

Date of Registration in Primary Registry:

02/08/2018

Record Verification Date:

2018/08/02

Next update date:

2019/08/02

Link to the spanish version:

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NeuroEPO in stroke

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