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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT06273020 (opens ClinicalTrials.gov in a new tab)Other idMI22-00013
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Mexico

Start
17 Nov 2022
Primary completion
Nov 2024 (estimated)
Completion
Dec 2024 (estimated)
First posted
22 Feb 2024
Last update posted
22 Feb 2024
Conditions
Ischemic Stroke, Acute · Diabetes Mellitus, Type 2 · Blood Brain Barrier

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 4

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

    NCT06273020

    17 Nov 2022 to est. Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • CerebrolysinDrug
  • Brain-MRI with contrast after 10-14 days of cerebrolysinProcedure

Arms3

  • Experimental

    Intravenous thrombolysis and cerebrolysin

    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

  • Active comparator

    Intravenous thrombolysis without 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.

  • Other

    Patients with cerebrolysin without IVT

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery

    Time frame · After 10-14 days of cerebrolysin

    Registry description

    Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging (MRI).DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2\*-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue. The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.

Secondary outcomes(3)

  1. Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin

    Time frame · After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge

    Registry description

    The NIH Stroke Scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups

  2. Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin

    Time frame · After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge

    Registry description

    The modified Rankin scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups

  3. Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin

    Time frame · fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge

    Registry description

    The Montreal Cognitive Assessment would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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