Ischemic Stroke, AcutePhase 4NCT06273020
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
A Phase 4 study testing Cerebrolysin and Brain-MRI with contrast after 10-14 days of cerebrolysin in people with Ischemic Stroke, Acute and Diabetes Mellitus, Type 2, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Diabetes Mellitus, Type 2, Blood Brain Barrier
- What is being tested?
- Cerebrolysin and Brain-MRI with contrast after 10-14 days of cerebrolysin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 17 Nov 2022to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
- mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
- The patient and/or legal representative or direct family member has signed the informed consent form.
Who cannot join
- 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 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).
- 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 of Cerebrolysin.
- Treatment with another investigational drug within the past 30 days that may interfere with the study drug.
Trial locations and contacts
1 site in 1 country.
Servicio de Neurología del Hospital Universitario "Dr.José E. González" contact
Mexico1 site, 1 recruiting
- Recruiting
Servicio de Neurología del Hospital Universitario "Dr.José E. González"
Nuevo León, Monterrey, 64020
Servicio F de Neurología del Hospital Universitario "Dr.José E. González", +528183591111, neurologiahu.posgrado@gmail.com
José C Becerra-Cruz, M.D., +522324393970, becerracruz@hotmail.com
About this study
Official title: The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
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
Read the 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
- Being tested
- Cerebrolysin, Brain-MRI with contrast after 10-14 days of cerebrolysin
- Keywords
- stroke, diabetes mellitus type 2
- Medical subject headings
- Ischemic Stroke, Diabetes Mellitus, Type 2, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
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
Brain-MRI with contrast after 10-14 days of cerebrolysinProcedure or surgery
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. 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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous thrombolysis and cerebrolysin | Experimental | 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 Receives: Drug: Cerebrolysin; Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin |
| Intravenous thrombolysis without cerebrolysin | Active comparator | Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization. Receives: Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin |
| Patients with cerebrolysin without IVT | Other | 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 Receives: Drug: Cerebrolysin; Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
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.
Measured: After 10-14 days of cerebrolysin
Secondary outcomes (3)
Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin
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
Measured: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin
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
Measured: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin
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
Measured: fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start17 Nov 2022
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Ever Neuro Pharma GmbH
- Responsible party
- Principal investigator, Juan Fernando Góngora Rivera, MD, PhD, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Juan F Góngora-Rivera, Ph.D., Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273020
- Sponsor's protocol ID
- MI22-00013
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data would be shared upon reasonable request after the publication of this trial in an indexed journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06273020
- Acronym / sponsor ID
- MI22-00013
- Keywords
- stroke, diabetes mellitus type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Collaborators
- Ever Neuro Pharma GmbH
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intravenous thrombolysis and cerebrolysin | Experimental | Drug: Cerebrolysin, Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysinGroup 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 |
| Intravenous thrombolysis without cerebrolysin | Active comparator | Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysinGroup 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization. |
| Patients with cerebrolysin without IVT | Other | Drug: Cerebrolysin, Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysinGroup 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
Key exclusion criteria (8 listed)
- 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 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).
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebrolysinCerebrolysin 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 | Drug | Intravenous thrombolysis and cerebrolysin, Patients with cerebrolysin without IVT |
| Brain-MRI with contrast after 10-14 days of cerebrolysinBlood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. 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. | Procedure or surgery | Intravenous thrombolysis and cerebrolysin, Intravenous thrombolysis without cerebrolysin, Patients with cerebrolysin without IVT |
Primary outcome
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
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes. The individual participant data would be shared upon reasonable request after the publication of this trial in an indexed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Servicio de Neurología del Hospital Universitario "Dr.José E. González" contact
Juan F Góngora-Rivera, Ph.D. principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cerebrolysin and Brain-MRI with contrast after 10-14 days of cerebrolysin in people with Ischemic Stroke, Acute and Diabetes Mellitus, Type 2, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan F Góngora-Rivera, Ph.D. (+528115163257, fernando.gongora@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.