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

NCT06700824 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: MATRISS-II2024-A01526-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Endovascular Thrombectomy; Ischemic Cerebrovascular Accident

Keywords

OTR4132; RGTA; neuroprotective agents; randomized controlled trial; ischemic stroke; endovacular thrombectomy

Outcome Measures

Primary Outcomes (1)

• Baseline-Adjusted 24-Hour NIHSS

  The NIH Stroke Scale (NIHSS) is based on the collection of 15 clinical neurological items. It allows for an accurate and rapid assessment of observed deficits. A large number of publications have shown that the NIHSS score at 24 hours is the best prognostic factor for long-term functional disability and is closely correlated with disability scores at 3 months. An NIHSS score between 1 and 4 means a minor stroke, between 5 and 15, a moderate stroke, above 15 points, a severe stroke. The maximum score is 42

  24 hours

Secondary Outcomes (4)

• Change in modified Rankin scale (mRS) at 3 months

  3 months

• Changes in total lesion volume from baseline to 3 months (MRI)

  3 months

• The rate of Intracranial hemorrhage at 24-hour

  24 hours

• Barthel Index at 3-months

  3 months

Study Arms (2)

OTR4132

EXPERIMENTAL

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: OTR4132

Placebo

PLACEBO COMPARATOR

Saline solution

Device: Placebo

Interventions

OTR4132 DEVICE

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.

OTR4132

Placebo DEVICE

saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years
• Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
• Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
• Endovascular thrombectomy (with or without previous intravenous thrombolysis)
• Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
• NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11
• Pre-stroke modified Rankin Score (mRS): 0 or 1
• Patient\* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent.
• Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study

You may not qualify if:

• Previous symptomatic stroke with permanent sequelae
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
• Contraindication to MRI
• Stroke lesion not visible on MRI
• History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
• History of hypersensitivity or anaphylactic reactions to iodinated contrast media
• Pregnant or breastfeeding women
• Severe renal failure with glomerular filtration rate (GFR) \< 30 mL/min
• Severe uncontrolled arterial hypertension e.g. systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, or intravenous medication necessary to reduce blood pressure
• Life expectancy of less than 3 months or co-morbidities that could influence the study results or would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult
• Increased risk of hemorrhage (for instance medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of suspected intracranial hemorrhage, symptoms suggestive of subarachnoid hemorrhage, even if the MRI is normal, international normalized ratio (INR)\>1.3 or activated partial thromboplastin time (aPTT)\>ULN (upper limit of normal)
• Suspected cerebral vasculitis based on medical history and imaging
• Occlusions in multiple vascular territories
• Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention)
• Worsening of medical or neurological conditions or per-procedures complications

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead
• Euraxi Pharma: collaborator

Study Sites (15)

Centre Hospitalier Universi-taire de Bordeaux-Hôpital Pellegrin

Bordeaux, 33076, France

Location

Centre hospitalier universi-taire de Brest (Cavale Blanche)

Brest, 29609, France

Location

CHU Henri-Mondor

Créteil, 94000, France

Location

Centre Hospitalier Universitaire de Martinique

Fort de France, 97261, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Centre Hospitalier Régional Universitaire de Lille- Hôpital Roger Salengro

Lille, 59000, France

Location

Hôpitaux Universitaires De Marseille Timone-AP-HM

Marseille, 13385, France

Location

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

Location

UIC Imagerie et Neurovasculaire CHU de Nantes

Nantes, 44093, France

Location

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, 75013, France

Location

Hôpital Fondation Adolphe de Rothschild Service de neuro-vasculaire

Paris, 75019, France

Location

GHU Paris Psychiatrie & Neurosciences

Paris, France, France

Location

Centre Hospitalier Universitaire de la Guadeloupe

Pointe à Pitre, 97159, France

Location

Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier Detante, MD

  Centre Hospitalier Universitaire Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic SEDEL, MD, PhD

CONTACT

+33 (0)1 83 62 78 91; frederic.sedel@otr3.com

Martin Inizan

CONTACT

+33 (0)1 83 62 78 91; martin.inizan@otr3.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: February 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

FR (15)