Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Stroke, Acute; Diabetes Mellitus, Type 2; Blood Brain Barrier

Treatments: Drug: Cerebrolysin; Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06273020

MI22-00013

Details and patient eligibility

About

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes

Full description

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).

The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.

The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 - 80 years.
2. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
3. Acute non-lacunar cerebral infarction.
4. Cerebral infarction with a score on the NIH scale between 5 and 20 points.
5. Patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
7. The patient and/or legal representative or direct family member has signed the informed consent form.

Exclusion criteria

1. Advanced disease or terminal with life expectancy < 6 months.
2. • Over 80 years old
3. Lacunar infarction or small vessel disease.
4. Pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse).
5. Pregnancy or lactation.
6. Acute or chronic renal failure with creatinine clearance <30 mL/min.
7. Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
8. Treatment with another investigational drug within the past 30 days that may interfere with the study drug.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Intravenous thrombolysis and cerebrolysin

Experimental group

Description:

Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin. Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days

Treatment:

Drug: Cerebrolysin

Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin

Intravenous thrombolysis without cerebrolysin

Active Comparator group

Description:

Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.

Treatment:

Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin

Patients with cerebrolysin without IVT

Other group

Description:

Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used) Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days

Treatment:

Drug: Cerebrolysin

Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin