NCT04486430

Brief Summary

The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

July 22, 2020

Last Update Submit

July 23, 2020

Conditions

StrokeCerebral Infarction

Keywords

Strokethe Salfaprodil for injectionNeu2000KWLNeuroprotectionglutamatefree radical

Outcome Measures

Primary Outcomes (1)

  • The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.

    The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.

    days:14±2

Secondary Outcomes (3)

  • Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection. 1. Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.

    days 14±2, 30±2 and 90±7

  • Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.

    days 14±2, 30±2 and 90±7

  • Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.

    days 14±2, 30±2 and 90±7

Other Outcomes (1)

  • Exploratory Imaging Analysis for Infarct Measurement

    day 6±1

Study Arms (4)

Neu2000KWL 2750mg dose group

EXPERIMENTAL

Low dose group

Drug: Neu2000KWL

Neu2000KWL 5250mg dose group

EXPERIMENTAL

Middle dose group

Drug: Neu2000KWL

Neu2000KWL 6000mg dose group

EXPERIMENTAL

High dose group

Drug: Neu2000KWL

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebos

Interventions

Neu2000KWLDRUG

1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours

Also known as: Salfaprodil for injection
Neu2000KWL 2750mg dose group
PlacebosDRUG

1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours

Placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 35 and 75 years;
  • acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;
  • patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;
  • patients within 6 hours of onset or the last time known to be symptom free (within 6 hours of the start of sleep for ischemic stroke patients with onset during sleep), and who receive a CT test before the clinical study;
  • Informed consent should be signed from the patient or patient's legally authorized representative;
  • patients with premorbid mRS score of 0\~1;
  • patients with no history of myocardial infarction within last 3 months;
  • patients with no heart, liver, kidney and lung function deficit;
  • patients with no hemorrhagic diseases within last 3 months;
  • patients with no haematological diseases.

You may not qualify if:

  • Any contraindication to CT and MRI (e.g., metal implants such as pacemakers, claustrophobia);
  • Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);
  • Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;
  • Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;
  • Pregnant or lactating women. Note: the pregnancy test of fertile women must be negative before randomization into groups, and female patients must take appropriate contraceptive methods at least for 3 weeks prior to the clinical study and over the next 7 days following the last injection of test drugs;
  • Pre-existing medical, neurologic, or psychiatric diseases that would confound the neurologic, functional, or imaging evaluations, such as persistent deficit from previous ischemic stroke;
  • Malignant tumor or other critical disease;
  • Patients with a history of epilepsy or undergoing seizure on onset of the ischemic stroke
  • A history of intracranial hemorrhage;
  • Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in three consecutive times after admission;
  • A history of severe injury and surgical operation within the last 3 months;
  • Consciousness disorder as defined as "NIHSS Ia score ≥2 ";
  • Complete atrioventricular block bradycardia;
  • Cardiac function rating above II level according to the New York heart association (NYHA) grade of cardiac function, history of congestive heart failure (CHF);
  • With primary liver and kidney disease, AST or ALT 2 times greater than upper normal limit, serum creatinine \>2.0 mg/dL or \>176.8 µmol/L;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Stroke Association

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

StrokeCerebral Infarction

Interventions

Injections

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Meng Wang, MD, Ph.D

    IRB of Beijing Tiantan Hospital, Capital Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Tian Tan Hospital, Director of Neurology Center

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

March 2, 2017

Primary Completion

June 12, 2019

Study Completion

December 13, 2019

Last Updated

July 24, 2020

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)