Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral He… (NCT03338998) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
United States32 participantsStarted 2017-12-24
Plain-language summary
This is a randomized, placebo-controlled, subject and investigator-blinded study to evaluate efficacy, safety and tolerability of BAF312 in participants with intracerebral hemorrhage (ICH)
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion 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
✕. 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.
What they're measuring
1
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)
✕. 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:
✕. Prior disability due to other disease compromising mRS evaluation, thereby interfering with the primary outcome, operationally defined as an estimated mRS score (by history) of ≥ 3 before ICH for patients less than or equal to 80 years of age. For ICH patients 81-85 years of age, estimated mRS by history prior to ICH must be less than or equal to 1 (no significant disability despite symptoms).