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

Last updated: February 15, 2024
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Stroke

Treatment

Cerebrolysin

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

Clinical Study ID

NCT06273020
MI22-00013
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 formof diagnosis, time of evolution, previous or current treatment, adherence or not totreatment, presence or absence of microvascular and/or macrovascular complications.
  6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities ofdaily living).
  7. The patient and/or legal representative or direct family member has signed theinformed consent form.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Cerebrolysin
Phase: 4
Study Start date:
November 17, 2022
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Servicio de Neurología del Hospital Universitario "Dr.José E. González"

    Nuevo León, Monterrey 64020
    Mexico

    Active - Recruiting

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