Evaluation of EGF plus GHRP-6 in moderate to severe ischemic 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.

Acronym of Public Title:

COURAGE-3

Scientific title:

Evaluation of the efficacy and safety of combined therapy of EGF plus GHRP-6 in the treatment of moderate to severe acute ischemic stroke.

Secondary indentifying numbers:

IG/CIGB-845I/IC/2603

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB)

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:

Juan

Midle name:

Humberto

Last name:

Gutierrez Ronquillo

Medical Specialty :

First and Second degree Specialist in Neurology

Affiliation:

“Arnaldo Milian Castro” University Hospital

Postal address:

Calle Nuevo Hospital, entre Doble Via y Circunvalacion

City:

Santa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-42270033

Email address:

amcentro@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, "Dr. Luis Diaz Soto" Central Military Hospital, Yaineris Parada, MD. irst and Second degree Specialist in Neurology

Matanzas, "Faustino Perez" Clinical Surgical Hospital, Leanet Martin Bernia, MD. First and Second degree Specialist in Neurology

Cienfuegos, “Dr. Gustavo Aldereguia” General University Hospital, Yoan Suit Carpio, MD. Specialist in Neurology (1st degree).

Ciego de Avila, “Dr. Antonio Luaces Iraola” Provincial General Teaching Hospital, Arasay Fuentes Mayo, MD. First degree Specialist in Neurology

Camaguey, “Manuel Ascunce Domenech” University Hospital, Nayade Perez Rodriguez, MD. First degree Specialist in Neurology

Holguin, "Lucía Inniguez Landin" Clinical Surgical Hospital, Yordanis Gongora Salazar, MD. First and Second degree Specialist in Neurology

Santiago de Cuba, “Saturnino Lora” Provincial Hospital, Elizabeth Colina Avila, MD. First and Second degree Specialist in Neurology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

21/12/2026

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:

Acute ischemic stroke of moderate to severe intensity.

Health condition(s) code:

Ischemic Stroke

Stroke

Cerebrovascular Disorders

Vascular Diseases

Cardiovascular Diseases

Brain Diseases

Central Nervous System Disease

Nervous System Disease

Health condition keyword:

-

Intervention(s):

Group I (Experimental): A dose of EGF (75 µg) and Growth Hormone Releasing Peptide-6 (GHRP-6, 5.0 mg) will be administered by slow intravenous bolus every 12 hours for 7 days (14 doses). Moreover, the standard therapy established in the country for the management of acute ischemic stroke will be administered (including stabilization, vital signs control, blood pressure, glycemia, temperature management, and antiplatelet therapy). Group II (Control): A dose of placebos of EGF and GHRP-6 will be administered by slow intravenous bolus every 12 hours for 7 days (14 doses). Moreover the standard therapy established in the country for the management of acute ischemic stroke will be administered (including stabilization, vital signs control, blood pressure, glycemia, temperature management, and antiplatelet therapy).

Intervention code:

Epidermal Growth Factor

Growth Hormone-Releasing Hormone

Peptides

Administration, Intravenous

Placebos

Intervention keyword:

EGF, recombinant Epidermal Growth Factor, GHRP-6

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. Degree of disability (It will assessed according to the modified Rankin Scale, (mRS): A 7-category system, where 0 indicates no residual stroke symptoms, 1 no significant disability, 2 mild disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 represents death). Measurement time: At discharge, and at 1 and 3 months. 2. Survival (Time from randomization to death from any cause). Measurement time: Up to 3 months.

Key secondary outcomes:

1. Change in Infarct Volume (ΔVolD4-VD30) (It will measured the change in the volume (mL) of the ischemic brain lesion between day 4 (considered the initial value due to edema) and day 30 (which approximates the final size of the lesion), evaluated by computed axial tomography (CAT), using the MicroDicom v2.0.0 and Amira v5.2.0 programs). Measurement time: Days 4 and 30. 2. Variation in Quality of Life (It will measured the variation in neurological health-related quality of life was assessed using the Neuro-QoL questionnaire, which uses a 5-point scale to rate items, with questions ranging from the lowest (1) to the highest (5). A T-score with a mean of 50 and a standard deviation of 10 was used. Higher scores indicate poorer health). Measurement time: Months 1 and 3. 3. Adverse Events-AE (Number and percentage of patients experiencing AE (Yes or No); Type (according to classification by affected system/organ and preferred term); Severity (According to CTCAE v6.0 criteria (Grade 1 to 5); Causal relationship (definite, probable, possible, improbable, unrelated, not evaluable)), Measurement time: Daily during admission, and in months 1 and 3.

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:

80 years

Inclusion criteria:

1. Fulfillment of diagnostic criteria for ischemic stroke. 2. Age between 19 and 80 years. 3. Time between symptom onset and first dose ≤ 12 hours. 4. NIHSS score ≥12 and ≤ 20. 5. Oral informed consent from the patient or family member.

Exclusion criteria:

1. Comatose patients (Glasgow Scale < 8). 2. When the neurological deficit can be explained by an entity other than ischemic stroke. 3. Severe and uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) that does not decrease after treatment. 4. Hypotension (systolic < 95 mmHg) unresponsive to usual treatment. 5. Clinical presentation with seizures. 6. Patients with baseline neurological disorders that could interfere with the functional assessment process. 7. Patients with a diagnosis of malignant neoplasms. 8. Pregnancy or lactation. 9. Evident mental incapacity to give consent. 10. History of stroke with significant sequelae (pre-morbid modified Rankin ≥ 2).

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:

3

Target sample size:

140

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:

Ivan

Last Name:

Campa Legra

Specialty:

Master in Clinical Trials; Bachelor in Pharmacy

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Avenida 31, entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72087465 (extension 106). Corporate mobile line: +53-59934964

Email :

ivan.campa@cigb.edu.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:

Diana

Last Name:

Garcia del Barco Herrera

Specialty:

Doctor of Medical Sciences; Doctor of Medicine; Specialist in Clinical Biochemistry (First and Second degree)

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Avenida 31, entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72716022

Email :

diana.garcia@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Arnaldo Miliáa Castro” University Hospital

“Dr. Luis Diaz Soto” Central Military Hospital

“Faustino Perez” Clinical-Surgical Hospital

“Dr. Gustavo Aldereguia” General University Hospital

“Dr. Antonio Luaces Iraola” Provincial General Teaching Hospital

“Manuel Ascunce Domenech” University Hospital

“Lucía Inniguez Landín” Clinical-Surgical Hospital

“Saturnino Lora” Provincial Hospital

Status of evaluation:

Approved

In review

Approved

Status of evaluation date of Ethic Committee:

01/07/2026

08/06/2026

24/06/2026

21/07/2026

22/06/2026

15/10/2026

08/06/2026

12/06/2026

Postal address of Ethic Committee :

Calle Nuevo Hospital, entre Doble Via y Circunvalacion, Santa Clara, Villa Clara, ZC:50100. Cuba

Ave. Monumental Km 2 ½ Carretera del Asilo, La Habana del Este, Havana, ZC:19130, Cuba

Carretera Central Km. 101, Matanzas, ZC:40100, Cuba

Calle 51 y Avenida 5 de Septiembre, Cienfuegos, ZC:55100, Cuba

Máximo Gomez # 257, Ciego de Avila, Cuba

Carretera Central Oeste, Camaguey, Cuba

Avenida Celia Sanchez # 1, Holguin, Cuba

Carretera Central s/n entre calle 4ta y Calle 6ta, Santiago de Cuba, Cuba

Telephone:

+53-42270355

+5352105519

+53-45247016

+53-43591100

+53- 33 212173

+53-32248382

+53-58395866

+53-58249457

Correo electrónico:

danielart@infomed.sld.cu

dlopezt@infomed.sld.cu

claralaucirica.mtz@infomed.sld.cu

blas.jorge@gal.sld.cu

marbelyst@infomed.sld.cu

gremb.cmw@infomed.sld.cu

aymaray@infomed.sld.cu

dirgneralhpsl@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

26/02/2027

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:

RPCEC00000489

Date of Registration in Primary Registry:

12/11/2026

Record Verification Date:

2026/11/12

Next update date:

2027/11/12

Link to the spanish version:

Click here

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Evaluation of EGF plus GHRP-6 in moderate to severe ischemic stroke

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