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NOT YET RECRUITING
NCT06700824
PHASE2

A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke

Sponsor: Organ, Tissue, Regeneration, Repair and Replacement

View on ClinicalTrials.gov

Summary

The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. The main objective will be to assess the efficacy of OTR4132-MD in patients with anterior ischemic stroke after endovascular thrombectomy. One dose will be tested (2 mg) against placebo. The main outcomes will be NIHSS (neurological score) at 24 hours, rate of intracranial hemorrhages at 24 hours, MRI lesion volume at 3 months and neurological scores at 3 months.

Official title: MATRISS-II. Matrix Therapy to Reduce Ischemic Stroke Sequelae-II. a Randomized-double Blinded- Placebo Controlled Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-02

Completion Date

2026-03

Last Updated

2024-11-26

Healthy Volunteers

No

Interventions

DEVICE

OTR4132

OTR4132 is a new ReGeneraTing Agent (RGTA®) which is a polymer of glucose (α-1,6 bounds, i.e. dextran backbone) engineered to mimic heparan sulphate (HS) in all three mechanical functions (extracellular matrix scaffold element, protector of matrix pro-teins and cellular communication peptides storage sites) but differ from HS by their resistance to glycanases. OTR4132 allows a restoration of the matrix architecture which secondarily facilitates cell survival and recovery at the site of injury.

DEVICE

Placebo

saline solution

Locations (15)

Centre Hospitalier Universi-taire de Bordeaux-Hôpital Pellegrin

Bordeaux, France

Centre hospitalier universi-taire de Brest (Cavale Blanche)

Brest, France

CHU Henri-Mondor

Créteil, France

Centre Hospitalier Universitaire de Martinique

Fort de France, France

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Centre Hospitalier Régional Universitaire de Lille- Hôpital Roger Salengro

Lille, France

Hôpitaux Universitaires De Marseille Timone-AP-HM

Marseille, France

Centre Hospitalier Régional Universitaire de Nancy

Nancy, France

UIC Imagerie et Neurovasculaire CHU de Nantes

Nantes, France

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, France

Hôpital Fondation Adolphe de Rothschild Service de neuro-vasculaire

Paris, France

GHU Paris Psychiatrie & Neurosciences

Paris, France

Centre Hospitalier Universitaire de la Guadeloupe

Pointe à Pitre, France

Hôpital de Hautepierre

Strasbourg, France

Hôpital Foch

Suresnes, France