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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Endovascular ThrombectomyIschemic Cerebrovascular Accident
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

Trial Locations (15)

13385

Hôpitaux Universitaires De Marseille Timone-AP-HM, Marseille

29609

Centre hospitalier universi-taire de Brest (Cavale Blanche), Brest

33076

Centre Hospitalier Universi-taire de Bordeaux-Hôpital Pellegrin, Bordeaux

38043

Centre Hospitalier Universitaire Grenoble Alpes, Grenoble

44093

UIC Imagerie et Neurovasculaire CHU de Nantes, Nantes

54000

Centre Hospitalier Régional Universitaire de Nancy, Nancy

59000

Centre Hospitalier Régional Universitaire de Lille- Hôpital Roger Salengro, Lille

67200

Hôpital de Hautepierre, Strasbourg

75013

Hôpital de la Pitié Salpêtrière - AP-HP, Paris

75019

Hôpital Fondation Adolphe de Rothschild Service de neuro-vasculaire, Paris

92150

Hôpital Foch, Suresnes

94000

CHU Henri-Mondor, Créteil

97159

Centre Hospitalier Universitaire de la Guadeloupe, Pointe à Pitre

97261

Centre Hospitalier Universitaire de Martinique, Fort de France

France

GHU Paris Psychiatrie & Neurosciences, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Euraxi Pharma

INDUSTRY

lead

Organ, Tissue, Regeneration, Repair and Replacement

INDUSTRY

NCT06700824 - A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients with Acute Ischemic Stroke | Biotech Hunter | Biotech Hunter