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

NCT06489925 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Basilar Artery Occlusion
  • Posterior Circulation Brain Infarction

Interventions

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.

Sponsors & Collaborators

  • Ever Neuro Pharma GmbH

    collaborator INDUSTRY

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Marina Roje Bedeković, MD, PhD · Sestre milosrdnice University Hospital Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489925 on ClinicalTrials.gov