Study to evaluate safety and effectiveness of NA-1 in reducing disability in stroke patients selected for mechanical clot removal procedures.

Phase 1

• Conditions: Acute Ischemic Stroke (AIS) in adult subjects with a large intracranial arterial occlusion, a small ischemic core, and good collaterals.; MedDRA version: 20.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: LLTClassification code 10074321Term: Nonhaemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: LLTClassification code 10074318Term: Nonhemorrhagic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001826-33-IE
• Lead Sponsor: oNO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-09
• Study Completion: 2019-11-20
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1105

Inclusion Criteria

Adults 18 years and older harboring an acute ischemic stroke and who are selected for endovascular revascularization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 392
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 728

Exclusion Criteria

Evidence of a large core of established infarction, absence of collateral circulation, weight >120kg or <45 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine the efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major AIS with a small established infarct core and with good collateral circulation selected for endovascular revascularization.;Secondary Objective: The secondary objectives are to determine the efficacy of NA-1 in:<br>• Reducing functional dependence<br>• Improving neurological outcome<br>• Improving activities of daily living<br>• Reducing mortality rate;Primary end point(s): The primary efficacy outcome variable for the pivotal assessment of efficacy for regulatory submission purposes is the overall proportion of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the modified Rankin Scale (mRS).;Timepoint(s) of evaluation of this end point: 90 days post-randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary efficacy outcome is the shift of one or more categories to reduced functional dependence analyzed across the whole distribution of scores on the mRS at Day 90 or the last rating.<br>Other secondary outcomes include:<br>1) Proportion of subjects with good neurological outcome, as defined by a score of 0-2 on the NIHSS at Day 90 or the last rating.<br>2) Proportion of subjects with functional independence in activities of daily living, as defined by a score of = 95 on the BI at Day 90 or the last rating.<br>3) A reduction in mortality rate, as defined by event rate (%) for mortality over the 90-day study period<br>4) Proportion of subjects with functional independence, as defined by a score of 0-1 on the mRS at Day 90 or the last rating.;Timepoint(s) of evaluation of this end point: At Day 90 or the last rating.