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Acute Ischemic Stroke Interventional Study

NCT03803007 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-10-06

No results posted yet for this study

Summary

To assess safety of single IV (bolus + infusion) doses of ACT017 in patients with an acute ischemic stroke in addition to best emergency standard of care (including fibrinolysis by rtPA with or without added thrombectomy), with a specific focus on hemorrhage, whether clinically symptomatic (NIHSS score + 4 points or death, without other explanation), or seen (excluding other diagnoses) on 24-hour (hr) CT scan, serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and medically important events and other safety items including biological and immunological tolerability.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Intravenous ACT017 1000 mg

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

OTHER

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
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2021-09-27
Completion
2021-09-27

Countries

  • France

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 NCT03803007 on ClinicalTrials.gov