Clinical trial NCT06273020: Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
Official title: The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke, Acute
Diabetes Mellitus, Type 2
Blood Brain Barrier
Keywords: stroke
diabetes mellitus type 2
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
Collaborators: name: Ever Neuro Pharma GmbH
First posted: 2024-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 groups in this clinical trial

Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.

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

Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
timeFrame: After 10-14 days of cerebrolysin
Secondary outcomes:
measure: Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin
timeFrame: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
measure: Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin
timeFrame: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
measure: Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin
timeFrame: fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Other outcomes:
Locations:
city: Nuevo León
country: Mexico
facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González"
state: Monterrey
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Juan F Góngora-Rivera, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: