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

A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy (ESCAPE-NA1 Trial) - ESCAPE-NA1 Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001826-33-GB

Enrollment

1120

Registered

2017-05-16

Start date

2017-07-19

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke (AIS) in adult subjects with a large intracranial arterial occlusion, a small ischemic core, and good collaterals. MedDRA version: 20.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10074321 Term: Nonhaemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic

Interventions

Product Name: H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH Product Code: NA-1 Pharmaceutical Form: Infusion INN or Proposed INN: H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-G

Peptide NA-1, chloride salt Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of adm

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 90 days post-randomization;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: • Reducing functional dependence • Improving neurological outcome • Improving activities of daily living • 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).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 90 days post-randomization;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: • Reducing functional dependence • Improving neurological outcome • Improving activities of daily living • 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).

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Secondary

Measure	Time frame
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. Other secondary outcomes include: 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. 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. 3) A reduction in mortality rate, as defined by event rate (%) for mortality over the 90-day study period 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.	—

Measure

Time frame

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. Other secondary outcomes include: 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. 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. 3) A reduction in mortality rate, as defined by event rate (%) for mortality over the 90-day study period 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.

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Countries

Australia, Canada, Germany, Ireland, Korea, Republic of, Sweden, United Kingdom, United States

Contacts

Public ContactMichael Tymianski, President & CEO

NoNO Inc.

mtymianski@nonoinc.ca+14166035188

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026