Clinical trial • Phase II • Other

LEVOSIMENDAN for Aneurysmal subarachnoid hemorrhage

Phase II trial of LEVOSIMENDAN for Aneurysmal subarachnoid hemorrhage. GLUCOSE 5 % B.BRAUN, solution pour perfusion (placebo)-controlled. 30 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Aneurysmal subarachnoid hemorrhage
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
04-11-2024

Trial design

GLUCOSE 5 % B.BRAUN, solution pour perfusion (placebo)-controlled Phase II trial across 1 site in France.

Comparator
GLUCOSE 5 % B.BRAUN, solution pour perfusion (placebo)
Target Sample Size
30

Eligibility

Recruits 30 Vulnerable population selected. Subject information and informed consent forms are provided for adults and for relatives/proxies (documents titled L1_SIS and ICF_adults; L1_SIS and ICF_proche; L1_SIS and ICF_proche Poursuite)..

Pregnancy Exclusion
pregnant women
Vulnerable Population
Vulnerable population selected. Subject information and informed consent forms are provided for adults and for relatives/proxies (documents titled L1_SIS and ICF_adults; L1_SIS and ICF_proche; L1_SIS and ICF_proche Poursuite).

Inclusion criteria

  • {"criterion_text":"- All adult patients (≥ 18 to 75),"}
  • {"criterion_text":"- hospitalized in surgical intensive care at Lariboisière for subarachnoid hemorrhage of aneurysm origin"}
  • {"criterion_text":"- (HSAa) clinical score WFNS I to IV and Fisher score 3 or 4."}

Exclusion criteria

  • {"criterion_text":"- Contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension, tachycardia, cardiac mechanical obstructions)"}
  • {"criterion_text":"- severe renal impairment (creatinine clearance <30 ml / min)"}
  • {"criterion_text":"- Severe hepatic insufficiency (signs of hepatic encephalopathy);"}
  • {"criterion_text":"- History of torsades de pointes"}
  • {"criterion_text":"- Severe pre-existing neuro-vascular pathologies"}
  • {"criterion_text":"- Moribund patients."}
  • {"criterion_text":"- pregnant women"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- the occurrence of cerebral arterial vasospasm within 14 days of the bleeding","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- the cumulative incidence of death rate, ICDs and vasospasms","definition_or_measurement_approach":"Evaluate mortality at Day 14, Day 28 and Day 90; occurrence of DCI within 14 days of the bleeding (secondary objective as specified in protocol)."}
  • {"endpoint_text":"- The mRS score at 6 months","definition_or_measurement_approach":"Modified Rankin Scale assessment at 6 months (endpoint text as provided)."}
  • {"endpoint_text":"- Impact of Levosimendan treatment on cardiac dysfunction","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
30
Recruitment Window Months
24
Consent Approach
Informed consent is handled using subject information and informed consent forms for adults (documents titled L1_SIS and ICF_adults) and separate forms for relatives/proxies (L1_SIS and ICF_proche and L1_SIS and ICF_proche Poursuite). No pediatric assent information or languages are specified in the provided record.

Geography

Total Number Of Sites
1
Total Number Of Participants
30

France

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
326
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-Réanimation
Principal Investigator Name
Benjamin CHOUSTERMAN
Principal Investigator Email
benjamin.chousterman@aphp.fr
Contact Person Name
Benjamin CHOUSTERMAN
Contact Person Email
alexandre.mebazaa@aphp.fr
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
GLUCOSE 5 % B.BRAUN, solution pour perfusion
Modality
Other
Investigational Product Name
ZIMINO 2,5 mg/ml, solution à diluer pour perfusion
Active Substance
LEVOSIMENDAN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
Marketing authorised (marketing authorisation number 34009 550 078 0 7, EU MP PRD4536834)
Maximum Dose
25 mg

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