Last updated 10 months ago
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
60 patients around the world
Available in Mexico
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
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
60Patients around the world
This study is for people with
Stroke
Ischemic stroke
Diabetes
Diabetes mellitus type 2
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Age 18 - 80 years.Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.Acute non-lacunar cerebral infarction.Cerebral infarction with a score on the NIH scale between 5 and 20 points.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.MRS ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).The patient and/or legal representative or direct family member has signed the informed consent form.
- Advanced disease or terminal with life expectancy < 6 months.Over 80 years oldLacunar infarction or small vessel disease.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).Pregnancy or lactation.Acute or chronic renal failure with creatinine clearance <30 mL/min.Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.Treatment with another investigational drug within the past 30 days that may interfere with the study drug.
Sites
Servicio de Neurología del Hospital Universitario Dr.José Eleuterio González
Recruiting
SponsorHospital Universitario Dr. Jose E. Gonzalez
Conditions
Ischemic strokeDiabetes mellitus type 2
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06273020
