NanO2 in Large VessEL Occlusion Stroke (NOVEL)

NCT06821347 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GN21ST331NIHR151755
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This is a National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) clinical trial aiming to investigate a possible new treatment to limit damage to the brain caused by a stroke. Strokes that are caused by a clot blocking an artery in the brain ('ischaemic' strokes) starve brain tissue of oxygen and nutrients. Over a short period of time without oxygen, this tissue becomes permanently damaged. The trial aims to investigate the effects of a drug that carries extra oxygen, called NanO2, on the amount of brain tissue damage. By carrying extra oxygen to brain tissue NanO2 may allow the tissue to survive for longer. It might be especially useful to prevent further damage happening while treatments to try and open the blocked blood vessel are given. Treatments may include 'clot-busting' drugs, or procedures to physically open a blocked artery. These treatments are very effective, but take time to successfully open the blockage. The study will involve treating people as early as possible after the stroke, and comparing brain scans before and after treatment. Patients diagnosed with a stroke that has occurred within the past 9 hours will be eligible to participate. The study will involve 8-15 hospitals across the UK. Participation in the study will last approximately 90 days. The majority of the study assessments will be during the first 5 days during inpatient hospital stay. There will be a telephone follow-up at 30 days and 90 days post-discharge.

Conditions

Stroke Acute

Keywords

acute ischaemic stroke; large vessel occlusion; thrombolysis

Outcome Measures

Primary Outcomes (1)

• Volume of penumbral tissue salvaged based on follow-up imaging (diffusion weighted MRI, or non-contrast CT if MRI cannot be obtained) compared with pre-treatment penumbral tissue volume from CT Perfusion.

  Baseline to 24hrs

Secondary Outcomes (10)

• National Institutes of Health Stroke Scale (NIHSS) change from baseline to day 5

  Baseline to Day 5

• NIHSS score change from baseline to 24h

  Baseline to 24hrs

• 24 hour NIHSS score

  Baseline to 24hrs

• Proportion achieving substantial early neurological improvement (NIHSS score reduced by ≥8 points or a score equal to 0 or 1) at 24 hours

  Baseline to 24hrs

• Distribution of modified Rankin Scale (mRS) scores at 30 and 90 days

  Baseline to Day 30 and Day 90

Study Arms (2)

NanO2

EXPERIMENTAL

Drug: NanO2TM

Placebo

PLACEBO COMPARATOR

Other: Sodium Chloride 0.9% Intravenous

Interventions

NanO2TM DRUG

Intravenous NanO2 0.17ml/kg (three doses given over 4.5 hours)

NanO2

Sodium Chloride 0.9% Intravenous OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female aged ≥ 18 years
• Acute ischemic stroke fulfilling perfusion imaging criteria (ischemic core volume \< 70 mL, mismatch ratio \> 1.8 and mismatch volume \> 15 mL using RAPID or equivalent CE-marked software)
• Eligible for thrombolysis or thrombectomy
• Intracranial LVO on CTA (occlusion of the terminal ICA, MCA-M1, ≥1 proximal MCA-M2, or proximal posterior cerebral artery (PCA-P1))
• ≤ 9 hours after last known well (if waking with symptoms, last known well time is calculated as the mid-point between going to sleep and waking)
• Pre-stroke functional independence (estimated pre-stroke mRS ≤2)
• NIHSS score ≥ 6 (or NIHSS ≥ 2 if PCA-P1 occlusion) at randomisation

You may not qualify if:

• History of significantly impaired renal eGFR (\<30ml/min) or hepatic function (transaminases \>3 times upper limit of normal or history of cirrhosis), unstable angina or heart failure (NYHA 3 or 4).
• Previous hypersensitivity reaction to NanO2 excipients and/or compounds similar to NanO2
• Pregnancy (for women of child-bearing potential a negative pregnancy test will be required prior to randomisation) or breast feeding women.
• Women of child-bearing potential is defined as experienced menarche; AND not undergone successful surgical sterilisation (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy); AND not post-menopausal i.e. amenorrhea for ≥12 consecutive months (without another medical cause)
• Participation in another CTIMP within preceding 90 days or 5 half-lives of the investigational product, whichever is longer, or previous participation in NOVEL.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• NuvOx LLC: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Keith Muir

CONTACT

+44 141 451 5892; Keith.Muir@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statisticians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 12, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-02

Locations

GB (1)