Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).

Inclusion Criteria

ICH patients eligible for inclusion in this study must fulfill all of the following criteria:

• Male or female patients aged 18 to 85 years (inclusive).
• 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.
• Spontaneous, supratentorial intracerebral hemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 10 mL but ≤ 60 mL (calculated by the ABC/2 method, after Kothari et al 1996) determined by routine clinical MRI or CT.
• Patients with the onset of ICH witnessed and/or last seen healthy no longer than 24 hrs previously.
• Patients with Glasgow Coma Scale (GCS) best motor score no less than 5 (brings hands above clavicle on stimulus to head or neck).

Exclusion Criteria

ICH patients fulfilling any of the following criteria are not eligible for inclusion in this study:

• Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., fingolimod).
• Current use of concomitant medications with potent CYP2C9/3A4 inhibitory or induction potential.
• Infratentorial (midbrain, pons, medulla, or cerebellum) ICH.
• Candidates for surgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation. If during the treatment period surgical hematoma evacuation or surgical intervention to lower intracranial pressure becomes indicated, the investigational treatment should be stopped.
• Patients with intraventricular hemorrhage (IVH) having a Graeb score of >3 on initial presentation. Patients must not have blood in the 4th ventricle and may only have blood in the 3rd ventricle in the absence of ventricular expansion. Trace or mild hemorrhage in either or both lateral ventricles is permitted. Patients with hydrocephalus determined radiologically on initial presentation are excluded regardless of Graeb score.
• Secondary ICH due to:
• aneurysm
• brain tumor
• arteriovenous malformation
• thrombocytopenia, defined as platelet count of 220 msec. Long QT syndrome or QTcF prolongation >450 msec in males or >470 msec in females on screening electrocardiogram (ECG).
• Patients receiving treatment with QT-prolonging drugs having a long half-life (e.g., amiodarone).
• Any of the following abnormal laboratory values prior to randomization:
• White blood cell (WBC) count < 2,000/μl (< 2.0 x 109/L)
• Lymphocyte count < 800/μl (< 0.8 x 109/L)
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Patients with any other medically unstable condition or serious laboratory abnormality as determined by the investigator.