At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
BAF312 solution +3 moredrug
Likely dose
BAF312 solution 4.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Patient- and Investigator-blinded, Randomized, Placebo-controlled Study to Evaluate Efficacy, Safety and Tolerability of BAF312 (Siponimod) in Patients With Stroke Due to Intracerebral Hemorrhage (ICH)
In Brief
A Phase 2 clinical trial evaluating BAF312 solution, Matching Placebo for BAF312 solution, and 2 other interventions for Hemorrhagic Stroke and Intracerebral Hemorrhage (ICH). Completed, enrolled 32 participants across 11 sites.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhagic Stroke, Intracerebral Hemorrhage (ICH)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartDec 2017
Primary CompletionMay 2020
TodayJul 2026
First PostedNov 9, 2017
Enrollment StartDec 24, 2017
Primary CompletionMay 13, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.6 years ago
Interventions
BAF312 solutiondrug
Solution for intravenous (IV) infusion - 4.5mg/4.5mL
Matching Placebo for BAF312 solutiondrug
Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo
BAF312 tabletdrug
2 mg film-coated tablet
Matching Placebo for BAF312 tabletdrug
0 mg film-coated tablet matching placebo