Basilar Artery OcclusionEarly Phase 1NCT06489925
Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
A Early Phase 1 study testing Cerebrolysin in people with Basilar Artery Occlusion and Posterior Circulation Brain Infarction, run by University Hospital Sestre Milosrdnice.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Occlusion, Posterior Circulation Brain Infarction
- What is being tested?
- Cerebrolysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to May 2026
- Phase
- Early Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Acute basilar artery occlusion confirmed on MSCT/ MR angiography
- Premorbid mRS ≤ 3
- Signed written consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Ivona Jerković, MD contact
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Cerebrolysin
- Keywords
- Cerebrolysin, neuroprotection, basilar artery occlusion, add-on therapy, posterior circulation stroke
- Medical subject headings
- Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin group | Experimental | 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. Receives: Drug: Cerebrolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 90 days (3 months) after the stroke
Mortality rate in the Cerebrolysin group compared to historical controls
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.
Measured: 90 days (3 months) after the stroke
Secondary outcomes (2)
Change in any and symptomatic intracerebral bleeding in the Cerebrolysin group compared to historical controls
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".
Measured: 24 hours and 14 days after the stroke
Change in the National Institutes of Health Stroke Scale (NIHSS) compared to historical controls
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.
Measured: 24 hours, 14 days, and 90 days after the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Basilar Artery OcclusionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Collaborators
- Ever Neuro Pharma GmbH
- Responsible party
- Principal investigator, Marina Roje Bedekovic, University Hospital Sestre Milosrdnice
- Investigators
- Marina Roje Bedeković, MD, PhD, Principal investigator, Sestre milosrdnice University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489925
- Sponsor's protocol ID
- 251-29-11/3-24-08
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hawkes MA, Blaginykh E, Ruff MW, Burrus T, Wijdicks EFM, Rabinstein AA. Long-term mortality, disability and stroke recurrence in patients with basilar artery occlusion. Eur J Neurol. 2020 Mar;27(3):579-585. doi: 10.1111/ene.14126. Epub 2019 Dec 8.
PubMed 31721389Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.
PubMed 19834014Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.
PubMed 23009193Khasanova DR, Kalinin MN. Cerebrolysin as an Early Add-on to Reperfusion Therapy: Risk of Hemorrhagic Transformation after Ischemic Stroke (CEREHETIS), a prospective, randomized, multicenter pilot study. BMC Neurol. 2023 Mar 27;23(1):121. doi: 10.1186/s12883-023-03159-w.
PubMed 36973684Guekht A, Vester J, Heiss WD, Gusev E, Hoemberg V, Rahlfs VW, Bajenaru O, Popescu BO, Doppler E, Winter S, Moessler H, Muresanu D. Safety and efficacy of Cerebrolysin in motor function recovery after stroke: a meta-analysis of the CARS trials. Neurol Sci. 2017 Oct;38(10):1761-1769. doi: 10.1007/s10072-017-3037-z. Epub 2017 Jul 13.
PubMed 28707130Poljakovic Z, Supe S, Ljevak J, Starcevic K, Peric I, Blazevic N, Krbot-Skoric M, Jovanovic I, Ozretic D. Efficacy and safety of Cerebrolysin after futile recanalisation therapy in patients with severe stroke. Clin Neurol Neurosurg. 2021 Aug;207:106767. doi: 10.1016/j.clineuro.2021.106767. Epub 2021 Jun 18.
PubMed 34214867Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
PubMed 18815396