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

NCT06489925 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 251-29-11/3-24-08
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cerebrolysin; neuroprotection; basilar artery occlusion; add-on therapy; posterior circulation stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  24 hours and 14 days after the stroke

• Change in the National Institutes of Health Stroke Scale (NIHSS) compared to historical controls

  24 hours, 14 days, and 90 days after the stroke

Study Arms (1)

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.

Drug: Cerebrolysin

Interventions

Cerebrolysin DRUG

The Cerebrolysin will be administered at least one hour after the standard treatment and no later than 24 hours after the stroke symptom onset.

Also known as: Cerebrolysin®

Cerebrolysin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead
• Ever Neuro Pharma GmbH: collaborator

Related Publications (7)

• 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.

  PMID: 31721389 BACKGROUND

• Smith 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.

  PMID: 19834014 BACKGROUND

• Lang 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.

  PMID: 23009193 BACKGROUND

• Khasanova 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.

  PMID: 36973684 BACKGROUND

• Guekht 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.

  PMID: 28707130 BACKGROUND

• Poljakovic 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.

  PMID: 34214867 BACKGROUND

• Hacke 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.

  PMID: 18815396 BACKGROUND

MeSH Terms

Conditions

Brain Infarction

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Marina Roje Bedeković, MD, PhD

  Sestre milosrdnice University Hospital Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Roje bedeković, MD, PhD

CONTACT

0993787257; marina.roje.bedekovic@kbcsm.hr

Ivona Jerković, MD

CONTACT

ivona.jerkovic@kbcsm.hr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Marina Roje Bedeković, MD, PhD, neurologist

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07