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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 formof diagnosis, time of evolution, previous or current treatment, adherence or not totreatment, presence or absence of microvascular and/or macrovascular complications.
- mRs ≤ 1 before the qualifying stroke (functionally independent for all activities ofdaily living).
- The patient and/or legal representative or direct family member has signed theinformed consent form.
Exclusion
Exclusion Criteria:
- Advanced disease or terminal with life expectancy < 6 months.
- Over 80 years old
- Lacunar infarction or small vessel disease.
- 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).
- 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 ofCerebrolysin.
- 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
Connect with a study center
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Nuevo León, Monterrey 64020
MexicoActive - Recruiting
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