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A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke
Sponsor: Organ, Tissue, Regeneration, Repair and Replacement
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
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.
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