Intracerebral Hemorrhage MedDRA version: 21.1 Level: LLT Classification code 10022754 Term: Intracerebral hemorrhage System Organ Class: 100000004852
Conditions
Interventions
Product Name: Siponimod
Product Code: BAF312
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descr
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 80 years (inclusive) 2. Written informed consent obtained before any study assessment is performed. If the patient is not able to give the informed consent personally, consent by a relative or legal representative is acceptable 3. Spontaneous, supratentorial intracerebral hemorrhage in deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume = 10 mL but = 30 mL (calculated by the ABC/2method, after Kothari et al. 1996) determined by routine clinical MRI or CT 4. Patients with the onset of ICH witnessed and/or last seen healthy no longer than 24 hrs previously 5. Patients with Glasgow Coma Scale (GCS) motor score no less than 6 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Infratentiorial (midbrain, pons, medulla, or cerebellum) or cortical (lobar) ICH 2. Secondary ICH due to aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic brain injury (TBI), or disseminated intravascular coagulation (DIC) 3. Necessity for mechanical ventilation at screening 4. Candidates for surgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation 5. Patients with intraventricular hematoma, with or without hydrocephalus, on initial presentation 6. Patients with active systemic bacterial, viral or fungal infections on initial presentation 7. Current use of concomitant medications with potent CYP2C9/3A4 inhibitory or induction potential; intravenous immunoglobulin, immunosuppressive and/or chemotherapeutic medications 8. Cardiovascular exclusion criteria: i. Cardiac conduction or rhythm disorders including sinus arrest or sinoatrial block, heart rate 220 msec. Long QT syndrome or QTcF prolongation >450 msec in males or >470 msec in females on screening electrocardiogram (ECG) iii. Patients receiving treatment with QT-prolonging drugs having a long half-life (e.g., amiodarone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of BAF312 compared to placebo in ICH patients, as overall function improvement measured by the modified Rankin Scale (mRS) score on Day 90 after ICH;Secondary Objective: 1) To assess the safety of BAF312 in ICH patients 2) To evaluate the exposure of BAF312 in ICH patients ;Primary end point(s): Modified Rankin Scale (mRS);Timepoint(s) of evaluation of this end point: On day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Continuous assessment of Adverse Events throughout the study 2) Measurements of BAF312 concentrations in blood ;Timepoint(s) of evaluation of this end point: 1) 90 days 2) At 0.5, 2, and 6 hours after start of study drug infusion on Day 1; and before oral dosing on Days 8 and 14. | — |
Countries
Germany, Spain, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed