Cerebrolysin's effect on the blood-brain barrier in diabetic stroke patients
The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
This study is testing if cerebrolysin can improve the blood-brain barrier in people with diabetes who have had a stroke, comparing it to a standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Locations | 1 site (Nuevo León, Monterrey) |
| Trial ID | NCT06273020 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of cerebrolysin on the blood-brain barrier in patients who have experienced an ischemic stroke and have a history of type 2 diabetes. Conducted at the Neurology Department of the University Hospital 'Dr. José Eleuterio González', it aims to compare the effects of cerebrolysin with those of intravenous thrombolysis. The primary focus is to assess changes in blood-brain barrier permeability after 10 days of cerebrolysin administration, using brain MRI with contrast for evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a history of type 2 diabetes and an acute ischemic stroke of the middle cerebral artery.
Not a fit: Patients over 80 years old or those with advanced diseases or specific types of strokes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for diabetic patients suffering from ischemic stroke by enhancing blood-brain barrier function.
How similar studies have performed: While the approach of using cerebrolysin is promising, it is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nuevo León, Monterrey
- Servicio de Neurología del Hospital Universitario "Dr.José E. González" — Nuevo León, Monterrey, Mexico (Recruiting)
Study contacts
- Principal investigator: Juan F Góngora-Rivera, Ph.D. — Hospital Universitario Dr. Jose E. Gonzalez
- Study coordinator: Juan F Góngora-Rivera, Ph.D.
- Email: fernando.gongora@hotmail.com
- Phone: +528115163257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.