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Sphingosine-1-phosphate receptor modulator

BAF312 for Hemorrhagic Stroke

Phase 2
Waitlist Available
Led By Kevin N. Sheth, MD
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, and 14
Awards & highlights

Study 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)

Eligible Conditions
  • Hemorrhagic Stroke
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Perihematoma Edema (aPHE) Volume Measured by Computed Tomography (CT) Scan After Intracerebral Hemorrhage (ICH)
Secondary outcome measures
Plasma BAF312 Concentrations

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BAF312Experimental Treatment2 Interventions
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally
Group II: PlaceboPlacebo Group2 Interventions
Days 1 - 7, IV up titration; days 8 - 14, 10 mg (5 x 2 mg tablets) taken daily orally - matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAF312 tablet
2017
Completed Phase 2
~40
BAF312 solution
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,959 Total Patients Enrolled
1 Trials studying Hemorrhagic Stroke
186 Patients Enrolled for Hemorrhagic Stroke
Kevin N. Sheth, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
686 Total Patients Enrolled
~4 spots leftby Jul 2025
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