NanO2 in Large VessEL Occlusion Stroke (NOVEL)

NCT ID: NCT06821347

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NanO2

Group Type: EXPERIMENTAL

NanO2TM

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9% Intravenous

Intervention Type: OTHER

Placebo

Interventions

NanO2TM

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

Intervention Type: DRUG

Sodium Chloride 0.9% Intravenous

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or non-pregnant female aged ≥ 18 years

2. 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)

3. Eligible for thrombolysis or thrombectomy

4. Intracranial LVO on CTA (occlusion of the terminal ICA, MCA-M1, ≥1 proximal MCA-M2, or proximal posterior cerebral artery (PCA-P1))

5. ≤ 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)

6. Pre-stroke functional independence (estimated pre-stroke mRS ≤2)

7. NIHSS score ≥ 6 (or NIHSS ≥ 2 if PCA-P1 occlusion) at randomisation

Exclusion Criteria

1. 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).

2. Pre-existing lung disease requiring supplemental chronic or intermittent oxygen therapy (NB oxygen therapy given post-stroke is not an exclusion)

3. Previous hypersensitivity reaction to NanO2 excipients and/or compounds similar to NanO2

4. 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)

5. Participation in another CTIMP within preceding 90 days or 5 half-lives of the investigational product, whichever is longer, or previous participation in NOVEL.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NuvOx LLC

INDUSTRY

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, United Kingdom

Countries

United Kingdom

Central Contacts

Keith Muir

Role: CONTACT

Keith.Muir@glasgow.ac.uk

+44 141 451 5892

Facility Contacts

Keith Muir

Role: primary

Keith.Muir@glasgow.ac.uk

+44 141 451 5892

Other Identifiers

NIHR151755

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GN21ST331

Identifier Type: -

Identifier Source: org_study_id