Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion

July 8, 2024 updated by: Marina Roje Bedekovic, University Hospital "Sestre Milosrdnice"

Cerebrolysin as an Add-On Therapy to Standard Treatment of Posterior Circulation Stroke Secondary to Basilar Artery Occlusion

The standard therapy for acute ischemic posterior circulation stroke (PCS) often leads to poor functional outcomes and high mortality rates, despite all advances in reperfusion therapy. Recent trials have shown that adding Cerebrolysin, a cerebral neuroprotective agent, to standard therapy for patients with acute ischemic anterior circulation stroke is safe and leads to improved functional outcomes. The purpose of this study is to assess the effectiveness and safety of Cerebrolysin with standard treatment for patients with PCS secondary to basilar artery occlusion (BAO).

The plan is to conduct a prospective, single-center, single-arm, open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score (mRS) ≤3, treated with standard treatment (mechanical thrombectomy ± intravenous alteplase or conservative treatment) and Cerebrolysin as add-on therapy, compared with historical controls. Besides standard acute stroke assessment, standard treatment, and rehabilitation, the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days. The participants will be closely monitored, and neuroimaging findings and clinical outcomes will be obtained during the drug administration period, on discharge, one month, and 3 months after the treatment onset.

The primary endpoints are mRS (0-3) on day 90 and mortality rate 90 days after the stroke onset. The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min. 2 points on the National Institutes of Health Stroke Scale 24 hours, 14 days, 30 days, and 90 days post-stroke.

The investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to conduct a prospective, single-center, single-arm, open-label study with 20 acute basilar artery occlusion patients with premorbid modified Rankin Score (mRS) ≤3, treated with standard treatment (mechanical thrombectomy ± intravenous thrombolysis with alteplase or conservative treatment) and Cerebrolysin as add-on therapy, compared with historical controls.

All participants will receive the same standard of care and will be treated according to the latest European Stroke Organisation and American Stroke Organisation guidelines on acute stroke.

Besides standard acute stroke assessment, treatment, and acute rehabilitation, the participants who meet the eligibility criteria, are informed about the study and its potential risks, and have written informed consent, will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days. The Cerebrolysin administration will start no earlier than one hour after the standard treatment, and no later than 24 hours after the stroke symptom onset. All possible side-effects will be closely monitored and in case of any adverse effect, the drug administration will be stopped, and the participant will be excluded from the further trial.

The participants will be closely monitored and the data on possible drug side effects, adverse effects, clinical findings, laboratory findings, and neuroimaging findings will be stored in the centralized hospital database. The clinical assessment and imaging analysis will be performed by an unbiased third-party neurologist/neuroradiologist.

The clinical findings and outcomes will be quantified by the National Institutes of Health Stroke Scale (NIHSS) 24 hours, 14 days, 30 days, and 90 days post-stroke and by the Modified Rankin Scale on discharge and 90 days post-stroke. The participants will undergo CT/ MRI neuroimaging for intracranial bleeding detection during admission, 24 hours after the stroke, and on discharge from the hospital. An additional imaging will be performed if indicated.

The interventional group and historical controls will be matched 1:1 based on the site of the basilar artery occlusion (proximal, middle, distal part), and further matched by the National Institutes of Health Stroke Scale score on admission to hospital (0-4, 4-15,16-20, 21-42), premorbid Modified Rankin Scale score, MSCT brain findings on admission to hospital (ischemia/ no ischemia), time from symptom onset to treatment (0-3h, 3-6h, later than 6 h), age (+/- 5 years), type of treatment (conservative treatment, intravenous thrombolysis with alteplase, mechanical thrombectomy, intravenous thrombolysis with alteplase + mechanical thrombectomy), type of mechanical thrombectomy (intracranial basilar artery stenting performed/not performed), and comorbid arterial hypertension (yes or no).

The data for historical controls will be obtained retrospectively from the Central Hospital Database which contains demographic, clinical, laboratory, and neuroimaging records of all patients with posterior circulation stroke secondary to basilar artery occlusion treated in the same Center from January 2015 to May 2024. The data will be analyzed, and the results will be compared between the investigational group and historical controls.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Acute basilar artery occlusion confirmed on MSCT/ MR angiography
  • Premorbid mRS ≤ 3
  • Signed written consent

Exclusion Criteria:

  • Hypersensitivity to one of the components of the drug
  • Breastfeeding and pregnancy
  • Epilepsy, epileptic seizure
  • Severe renal impairment (grade IV and V)
  • Ischemic stroke in the previous three months
  • Metastatic cancer
  • Sepsis or a severe infection on admission
  • Acute coronary syndrome, pulmonary embolism, and deep venous thrombosis on admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebrolysin group
Patients with acute basilar artery occlusion who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml, diluted with 250 ml of 0.9% saline intravenously in the first 24 hours after the stroke. Cerebrolysin will be further administered in the same dosage once daily in the morning for 14 consecutive days.
Drug: Cerebrolysin
The Cerebrolysin will be administered at least one hour after the standard treatment and no later than 24 hours after the stroke symptom onset.
Other Names:
  • Cerebrolysin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants in the Cerebrolysin group with the Modified Rankin Scale (mRS) score 0-3 at 90 days post-stroke compared to historical controls
Time Frame: 90 days (3 months) after the stroke
The functional outcomes will be assessed using the Modified Rankin Scale (mRS), with scores ranging from 0 (best functional outcome) to 6 (worst functional outcome). In the context of posterior circulation stroke, a favorable functional outcome is defined as an mRS score of ≤3 on day 90 post-stroke.
90 days (3 months) after the stroke
Mortality rate in the Cerebrolysin group compared to historical controls
Time Frame: 90 days (3 months) after the stroke
The mortality rate will be assessed using the Modified Rankin Scale, which ranges from 0 to 6, where a score of 6 corresponds to the "death" outcome.
90 days (3 months) after the stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in any and symptomatic intracerebral bleeding in the Cerebrolysin group compared to historical controls
Time Frame: 24 hours and 14 days after the stroke

The follow-up computed tomography scans will be performed 24 hours and 14 days after the stroke. Additional scans will be obtained when indicated (before introducing anticoagulant therapy, in case of clinical deterioration with an increase of ≥4 points on the NIHSS from baseline or the lowest value within 7 days, in case of death, or for other reasons).

Types of intracerebral bleeding and symptomatic intracerebral bleeding will be classified according to the ECASS III trial classification. Other types of bleeding which cannot be classified by ECASS III classification will be listed as "other".
24 hours and 14 days after the stroke
Change in the National Institutes of Health Stroke Scale (NIHSS) compared to historical controls
Time Frame: 24 hours, 14 days, and 90 days after the stroke

The clinical outcomes will be evaluated using the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42. Lower scores indicate a better clinical outcome, while higher scores indicate a worse outcome.

A change of at least 2 points on the National Institutes of Health Stroke Scale (NIHSS) is considered significant.
24 hours, 14 days, and 90 days after the stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital "Sestre Milosrdnice"

Collaborators

Ever Neuro Pharma GmbH

Investigators

  • Principal Investigator: Marina Roje Bedeković, MD, PhD, Sestre milosrdnice University Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251-29-11/3-24-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Basilar Artery Occlusion

Clinical Trials on Cerebrolysin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe