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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)
Full description
This was the first trial of BAF312 in ICH patients to evaluate if BAF312 had the potential to limit brain inflammation after ICH, and thereby improve neurological outcome for stroke patients when administered in addition to standard of care.
ICH patients meeting study criteria were randomized at 1:1 ratio into either active or placebo group. Patients received an intravenous infusion (i.v.) treatment within 24 hours of an ICH event and were up titrated for 7 days. Following the i.v. treatment, participants received 10 mg BAF312 or placebo in tablet form (taken daily orally) for an additional 7 days. Participants were followed for an additional 76 days after treatment for neurological and safety conditions during three clinic visits.
Recruitment for the trial was put on hold due to the COVID-19 pandemic. Thirty-two patients had been enrolled in the trial and completed the protocol as planned. After seven months of the trial being on hold, an Interim analysis was conducted and reviewed by the Data Monitoring Committee. Novartis terminated the trial due to lack of potential efficacy.
Enrollment
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Inclusion criteria
ICH patients eligible for inclusion in this study must fulfill all of the following criteria:
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:
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).
Preexisting unstable epilepsy.
Patients with active systemic bacterial, viral or fungal infections.
Concomitant drug-related exclusion criteria:
Cardiovascular exclusion criteria:
Any of the following abnormal laboratory values prior to randomization:
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.
Primary purpose
Allocation
Interventional model
Masking
32 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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