NanO2 for Large Vessel Occlusion Stroke

NCT05389748 | Unknown Phase 2 FDA Drug

• 1 other identifier: PROVEN-P2
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

A two stage phase 2 study with an interim analysis to provide evidence that subjects provided with early administration of NanO2 who are located at small rural spoke hospitals and identified with large vessel occlusion ischemic strokes as well as viable penumbra prior to transfer to larger hub hospitals and who continue dosing NanO2 until revascularization is achieved by intravenous alteplase and/or mechanical thrombectomy, will experience stroke recovery by shifting ischemic brain tissue to normal tissue pO2 environments.

Conditions

Ischemic Stroke

Keywords

perfusion; penumbra; mechanical thrombectomy; large vessel occlusion stroke

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale and Modified Rankin Scale

  Both are established and accepted measures of stroke. NIHSS has a scale from 0 to 42 and mRS has a scale from 0 to 6. In both cases, a lower score represents less brain damage.

  2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo which appears the same as the treatment to investigators, clinicians and subjects.

Other: Placebo

NanO2

ACTIVE COMPARATOR

A milky white intravenous injectable emulsion

Biological: dodecafluoropentane emulsion (DDFPe)

Interventions

Placebo OTHER

Subjects with large vessel occlusion stroke eligible for mechanical thrombectomy are randomized to placebo in association with standard of care

Placebo

dodecafluoropentane emulsion (DDFPe) BIOLOGICAL

Subjects with large vessel occlusion stroke eligible for mechanical thrombectomy are randomized to DDFPe in association with standard of care

NanO2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 90 years old, male or female
• Diagnosis of LVO ischemic stroke
• Pre-stroke mRS ≤ 2
• NIHSS ≥ 6
• Eligible for mechanical thrombectomy per local criteria
• Subject or LAR must be willing and able to understand the study and provide written informed consent
• Women of childbearing potential or men with child-bearing potential partners (unless vasectomized) must agree to use a highly effective method of birth control from study entry until 4 months after completing study therapy. Should a study participant or their partner become pregnant or suspect a pregnancy they should inform the treating study physician immediately

You may not qualify if:

• \> 12 hours since onset of stroke symptoms
• Currently pregnant or breastfeeding
• History of significantly impaired renal or hepatic function
• Severe hemorrhage or severe hemorrhagic stroke on CT scan. Mild or moderate changes of Fisher Grade 1 or 2 subarachnoid hemorrhage are allowed as are hemorrhagic transformation changes of Grade HI-1 and HI-224,25
• Unable to undergo a contrast brain perfusion scan with either MRI or CT
• Pre-stroke mRS \> 2 (See Appendix 3)
• Unstable angina, NYHA Class II or greater congestive heart failure
• Uncontrolled hypertension (Systolic BP ≥ 200 and/or Diastolic BP ≤ 120 mmHg)
• Uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six (6) months (except atrial fibrillation)
• Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
• History of allergic reaction attributed to compounds of similar chemical composition to NanO2TM (see Investigator's Brochure).
• Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
• Inability to comply with the study procedures
• History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion

Sponsors & Collaborators

• NuvOx LLC: lead
• University of Arkansas: collaborator
• Stanford University: collaborator
• Washington Regional Medical Center: collaborator

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 25, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 25, 2022

Record last verified: 2022-05