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ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo

NCT05070260 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2024-07-03

No results posted yet for this study

Summary

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study.

The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Intravenous glenzocimab (ACT017) 1000 mg

Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms

DRUG

Intravenous Placebo

Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms

Sponsors & Collaborators

  • Acticor Biotech

    lead INDUSTRY

Principal Investigators

  • Andrea Comenducci, MD · Acticor Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

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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 NCT05070260 on ClinicalTrials.gov