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

NCT03338998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-12

Study results available
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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)

Conditions

  • Hemorrhagic Stroke
  • Intracerebral Hemorrhage (ICH)

Interventions

DRUG

BAF312 solution

Solution for intravenous (IV) infusion - 4.5mg/4.5mL

DRUG

Matching Placebo for BAF312 solution

Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo

DRUG

BAF312 tablet

2 mg film-coated tablet

DRUG

Matching Placebo for BAF312 tablet

0 mg film-coated tablet matching placebo

Sponsors & Collaborators

Principal Investigators

  • Kevin N. Sheth, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-24
Primary Completion
2020-05-13
Completion
2020-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338998 on ClinicalTrials.gov