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Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke

NCT04734548 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2022-10-21

No results posted yet for this study

Summary

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemic stroke patients who are candidates to receive reperfusion therapies.

Conditions

Interventions

DRUG

ApTOLL

ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatory response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.

OTHER

Placebo

White freeze-dried powder which is indistinguishable to ApTOLL for taste, color, texture and size.

Sponsors & Collaborators

  • Ministry of Science and Innovation, Spain

    collaborator OTHER_GOV

  • Anagram

    collaborator UNKNOWN

  • aptaTargets S.L.

    lead INDUSTRY

Principal Investigators

  • Marc Ribó, MD, PhD · aptaTargets S.L.

  • Macarena Hernández, PhD · aptaTargets S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2022-07-25
Completion
2022-09-07

Countries

  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT04734548 on ClinicalTrials.gov