drugset / Trial / NCT03338998

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

NCT03338998 ↗

Phase 2 Completed 32 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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)

Timeline

Start
2017-12-24
Primary completion
2020-05-13
Completion
2020-05-13

Outcome

Missed primary endpoint

registry analysis (superiority test); BAF312 vs Placebo; p = 0.585; Geo-mean ratio 1.05 (90% CI 0.717 to 1.535); ANCOVA NCT03338998 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BAF312 Unknown 10 mg Intravenous