EXENATIDE for Acute ischemic stroke

Inclusion criteria

• {"criterion_text":"- Aged 18 to 80 years, inclusive, at the time of signing the informed consent."}
• {"criterion_text":"- Patient with either no history of depression or treated for depression with a stable combination of antidepressants for at least 8weeks before inclusion in the study."}
• {"criterion_text":"- Patient with no known history of dementia."}
• {"criterion_text":"- Provision of signed informed consent by the patient or caregiver/legal representative, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol."}
• {"criterion_text":"- Expectation that the patient will receive standard physical, occupational, and speech rehabilitation therapies as indicated for post-stroke deficits."}
• {"criterion_text":"- Patient or caregivers understand study procedures and are willing to comply with them for the entire length of the study."}
• {"criterion_text":"- Confirmed diagnosis of AIS, according to the World Health Organization (WHO) definition, as diagnosed with CT."}
• {"criterion_text":"- Radiology-confirmed supratentorial IS; nonlacunar, >15 mm diameter in one direction as depicted in the CT scan."}
• {"criterion_text":"- NIHSS score at screening ≥5 and ≤20 points."}
• {"criterion_text":"- A maximum of 36 h may elapse from symptoms’ onset to treatment initiation."}
• {"criterion_text":"- Pre-stroke (36 hours prior to stroke onset) independent functional status in activities of daily living (ie, patients must have been living without requiring nursing care) based on information provided by the patient or his/her caregivers."}
• {"criterion_text":"- Patient not a candidate for thrombolysis with tPA."}
• {"criterion_text":"- Patient not a candidate for thrombectomy."}
• {"criterion_text":"- A diabetic patient must have been on a stable antidiabetic regimen at least 8 weeks before inclusion in the study."}

Exclusion criteria

• {"criterion_text":"- Allergy/sensitivity to study drugs or their ingredients."}
• {"criterion_text":"- Patient presenting with uncontrolled hypertension, blood glucose level >4 mmol/L, cancer, renal failure (defined as creatinine clearance <90 ml/min), evidence of acute myocardial infarction, acute pancreatitis, or other significant medical condition according to Investigator’s opinion."}
• {"criterion_text":"- Mental illness or psychiatric disease making the patient incapable of following/participating in this study, as assessed by the Investigator."}
• {"criterion_text":"- a. Alanine transaminase (ALT) [or aspartate transaminase (AST)] >2.0 x upper limit of normal (ULN) b. Total bilirubin >1.5xULN (Participants with Gilbert’s syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is ≤1.5 x ULN) c. Current or chronic history of liver disease."}
• {"criterion_text":"- Concurrent treatment with any of the investigational drugs in this study."}
• {"criterion_text":"- Participation in other clinical trials within 30 days before randomization, or currently involved in other clinical trials."}
• {"criterion_text":"- Signs of intracranial hemorrhage or suspected subarachnoid hemorrhage, as assessed based on CT imaging examination."}
• {"criterion_text":"- Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency (previously known or as confirmed at the clinical site)."}
• {"criterion_text":"- Treatment with medications/agents which are contraindicated based on the SmPCs of the combination IMPs for usage in combination with the study interventions."}
• {"criterion_text":"- Current drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements."}
• {"criterion_text":"- Inability or unwillingness of patient or caregiver/legal guardian/representative to give written informed consent."}
• {"criterion_text":"- Pregnancy or lactation, at screening."}
• {"criterion_text":"- Patient who plans to become pregnant within 6 months, or women in childbearing age with negative pregnancy test but who refuses to accept contraception."}
• {"criterion_text":"- Patient unlikely to be available for a 90-day follow-up (eg, life expectancy <3 months)."}
• {"criterion_text":"- Patients with contraindications with the combination of the drugs being studied."}
• {"criterion_text":"- Clinical presentation of a lacunar stroke according to site investigators."}
• {"criterion_text":"- Patient suffering from intracranial tumors, severe trauma, encephalitis, subarachnoid hemorrhage, or other brain organic diseases."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with hemorrhagic transformation as depicted in a CT or MRI.","definition_or_measurement_approach":"Hemorrhagic transformation assessed/documented by CT or MRI imaging."}

Secondary endpoints

• {"endpoint_text":"- Degree of disability based on the mRS score","definition_or_measurement_approach":"Measured using the modified Rankin Scale (mRS) score."}
• {"endpoint_text":"- •\tInfarct volume defined as MRI lesion volume on Day 5 •\tInfarct volume defined as MRI lesion volume on Day 90 •\tChange in DWI lesion volume from Day 5 to Day 90, based on MRI •\tChange in PWI lesion volume from Day 5 to Day 90, based on MRI","definition_or_measurement_approach":"MRI lesion volumes measured on Day 5 and Day 90; changes in DWI and PWI lesion volumes between Day 5 and Day 90."}
• {"endpoint_text":"- Change in recanalization of the occluded vessel based on MR angiography (MRA).","definition_or_measurement_approach":"Recanalization assessed by MR angiography (MRA) comparing baseline and follow-up imaging."}
• {"endpoint_text":"- Percentage of patients with clinically meaningful improvement in NIHSS score (improvement >4 points).","definition_or_measurement_approach":"Improvement determined by change in NIHSS score; clinically meaningful improvement defined as >4 points."}
• {"endpoint_text":"- • Percentage of patients treated with investigational combination therapy on top of BMT and those treated with BMT only, experiencing all-cause on-treatment AEs, analyzed for: o patients that complete the study period, and o\tpatients who discontinue from the study period due to an AE. •\tPercentage of patients with abnormal clinically significant laboratory test results.","definition_or_measurement_approach":"Adverse events recorded during treatment; analysis by completion status and discontinuation due to AE; clinically significant lab abnormalities summarized as percentages."}
• {"endpoint_text":"- All-cause mortality.","definition_or_measurement_approach":"All-cause deaths during study observation period (reported as counts/percentages)."}
• {"endpoint_text":"- •\tPercentage of patients who developed depression, defined as score >10 on the HAM-D17 •\tPercentage of patients who developed mild to moderate depression (HAM-D17 score: 14-17), or moderate to severe depression (HAM-D17 score: >17).","definition_or_measurement_approach":"Depression assessed by HAM-D17 scale; thresholds as stated (>10, 14-17, >17)."}
• {"endpoint_text":"- Percentage of change in blood biomarkers.","definition_or_measurement_approach":"Percent change in specified blood biomarkers from baseline to follow-up timepoints."}
• {"endpoint_text":"- • Observed plasma concentration • Minimum observed plasma concentration at steady state conditions","definition_or_measurement_approach":"Pharmacokinetic plasma concentrations measured; includes observed concentrations and minimum observed at steady state."}
• {"endpoint_text":"- Correlation of plasma concentrations of the investigational combination treatments with: • The percentage of patients experiencing overall AEs and specific AEs •\tDegree of disability based on the mRS score •\tThe percentage of patients who developed depression •\tThe percentage of patients with clinically meaningful improvement in NIHSS score •\tMRI response parameters •\tBiomarker levels •\tTreatment compliance","definition_or_measurement_approach":"Statistical correlation analyses between plasma concentrations and listed clinical, imaging, biomarker, safety, and compliance outcomes."}

Greece

Earliest CTIS Part Ii Submission Date

29-10-2025

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

106

Number Of Sites

9

Number Of Participants

150

Primary sponsor

Full Name

Genesis Pharma S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece

Contract research organisations

Name

Optimapharm Greece Consulting Research Single Member S.A.

Responsibilities

sponsorDuties codes: 1,10,11,12,2,5,6,7,8 (as listed in CTIS thirdParty entry)

Third parties

• {"country":"Greece","full_name":"Affidea Kifissia","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Greece","full_name":"University Of Patras","duties_or_roles":"Pharmacodynamics (sponsorDuties code: 15)","organisation_type":"Educational Institution"}
• {"country":"Greece","full_name":"QACS Ltd.","duties_or_roles":"Drugs quality control testing (microbiological) (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Labomed Pharmaceutical Company S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Optimapharm Greece Consulting Research Single Member S.A.","duties_or_roles":"Multiple sponsorDuties codes: 1, 10, 11, 12, 2, 5, 6, 7, 8 (operational/clinical support roles as listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Anfarm Hellas S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Tzartos Neurodiagnosticsiki","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}