- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831088
Safety and Optimal Neuroprotection of neu2000 in Ischemic Stroke With Endovascular reCanalizion (SONIC) (SONIC)
A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess Efficacy and Safety of Neu2000KWL in Patients With Acute Ischemic Stroke Receiving Endovascular Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chun San An
- Phone Number: 82-31-8005-9910
- Email: csan@gntpharma.com
Study Contact Backup
- Name: Sung Ig Cho
- Phone Number: 82-31-8005-9910
- Email: sicho@gntpharma.com
Study Locations
-
-
-
Cheongju, Korea, Republic of, 28644
- Recruiting
- Chungbuk National University Hospital
-
Daegu, Korea, Republic of, 41944
- Recruiting
- Kyungpook National University Hospital
-
Daegu, Korea, Republic of, 41931
- Recruiting
- Keimyung University Dongsan Medical Center
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Gwangju, Korea, Republic of, 61453
- Recruiting
- Chosun university hospital
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Incheon, Korea, Republic of, 21565
- Recruiting
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of, 16499
- Recruiting
- Ajou University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults ≥19 years
- Patients who were presented to hospitals after onset of brain ischemic symptoms from the base of last normal state and can start Endovascular therapy in accordance with standard practice guidelines within 8 hours after the symptom onset.
- NIHSS scores on screening time point (admission) ≥ 8 points
- Patients whose activity is possible without the help of others in the gen-eral condition one day before the ischemic stroke onset. and whose Barthel index scores exceed 90 points
Patients whose brain CT and CT angiography imaging confirmed acute ischemic stroke and symptomatic intracranial occlusion at screening and whose occlusion site considered the cause of acute ischemic stroke meets the following conditions:
① Carotid T or L type occlusion
② M1 MCA
③ M1-MCA equivalent (two or more M2-MCAs) However, anterior temporal artery is not regarded M2
- Patients with ASPECTS on Brain CT without early imaging hyper-enhancement ≥ 6
- Patients who spontaneously submitted a written informed consent to participation on this clinical study
Exclusion Criteria:
- a medical history of hypersensitivity against aspirin (salicylates), sulfasalazine or (5-ASA) at screening.
Patients who meets the exclusion criteria on imaging in intra-arterial re-canalization therapy ① CTA
Patients whose imaging shows that the site of occlusion considered the cause of acute ischemic stroke meets the following conditions:
A. MCA + PCA or MCA+ACA occlusion in Carotid T/L B. occlusion of a bilateral large artery C. simultaneous infiltration of anterior and posterior circulation
② absence of the collateral circulation corresponding to one of the followings: A. On CT angiography (MIP-CTA) imaging, absence or minimal collateral circulation at ≥50% of MCA territories, compared with pial filling of contralateral side of the lesion.
Patients whose heart diseases corresponding to following conditions were confirmed at screening:
① Patients who were diagnosed with myocardial infarction within 6 months at screening
② Patients who had severe arrhythmia evoking clinical symptoms (respiratory difficulties, tachycardia etc.) within 6 months at screening.
Patients whose ECG measured at the stable state at emergency room confirmed the following results:
A. pulse rate < 50 or >120 beats per minute B. 2nd or 3rd degree AV block is confirmed. C. congenital or acquired QT syndrome is confirmed D. ventricular pre-excitation syndrome is confirmed
Patients who were diagnosed with heart failure ≥ class II according to "heart failure classification by NYHA (New York Heart Association)" before screening.
"heart failure classification by NYHA (New York Heart Association)" Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
Class III: patients with marked limitation of activity; they are comfortable only at rest.
Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on.
- Patients who have contraindication to contrast media for brain imaging
- Patients who are receiving renal replacement therapy such as dialysis, due to acute or chronic renal failure, nephropathy, etc. at screening.
- Patients who were diagnosed with cancer or received cancer therapy within 6 months at screening or have recurrent or transitional cancer
- Patients who show high body temperature of 38℃ or more or who need antibiotic therapy due to medical opinion of infectious diseases at screening.
- Patients who take pharmacotherapy due to liver diseases such as hepatitis, liver cirrhosis etc. at screening.
- Patients who are pregnant or lactating. However, in case of a woman of child-bearing potential, only patients whose non-pregnancy was confirmed can participate in this clinical study.
- Patients who participated in other clinical studies within past 3 months at the screening time as a base. However, in case of participation in an observatory study without medication, the patients can participate in this clinical study.
- Patients who were determined unsuitable for participation in this clinical study due to other reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1st infusion of the same volume of saline in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 hours
|
Experimental: Neu2000KWL High-dose group
|
1st infusion of 750mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Other Names:
|
Experimental: Neu2000KWL Low-dose group
|
1st infusion of 500mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportional Ratios of study subjects with mRS 0-2 scores at 12 weeks after Neu2000KWL treatment
Time Frame: 12weeks
|
12weeks
|
Occurrence rate of cerebral hemorrhagic transformation occurring within 48 hours based on parenchymal hematoma (PH) criteria by ECASS (European Co-operative Acute Stroke Study)-I and II
Time Frame: 12weeks
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution changes of mRS scores at 1, 4 and 12 weeks vs baseline (shift analysis)
Time Frame: 1week, 4weeks, 12weeks
|
1week, 4weeks, 12weeks
|
|
Ratios of NIHSS 0-2 scores at 1, 4 and 12 weeks vs baseline
Time Frame: 1week, 4weeks, 12weeks
|
1week, 4weeks, 12weeks
|
|
Ratios of Barthel index >90 (≥ 95) at 1, 4 and 12 weeks vs baseline
Time Frame: 1week, 4weeks, 12weeks
|
1week, 4weeks, 12weeks
|
|
Occurrence rate of cerebral hemorrhagic transformation occurring within Day 4 or Day 5 (Day of the last treatment of the study drug)
Time Frame: 4-5days
|
based on parenchymal hematoma (PH) criteria by ECASS (European Co-operative Acute Stroke Study)-I and II
|
4-5days
|
Occurrence rate of symptomatic intracranial hemorrhage (SICH) described and defined by this study protocol occurring within Day 4 or Day 5 (Day of the last treatment of the study drug)
Time Frame: 4-5days
|
It is defined as SICH of intracranial hemorrhage by brain imaging is confirmed and any one of the following conditions is accompanied: A. in case that NIHSS scores become worse 2 points or more B. in case that NIHSS scores become worse 1 point or more, accompanying decreased consciousness C. in case that neurological deficits persist 24 hours or more (and), D. in case of recurrence of stroke and progress deterioration, or in case that other medical causes are not related. |
4-5days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ji Man Hong, MD, PhD, Ajou University Medical Centre
Publications and helpful links
General Publications
- Hong JM, Lee JS, Lee YB, Shin DH, Shin DI, Hwang YH, Ahn SH, Kim JG, Sohn SI, Kwon SU, Lee JS, Gwag BJ, Chamorro A, Choi DW; SONIC Investigators. Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial. Stroke. 2022 Nov;53(11):3250-3259. doi: 10.1161/STROKEAHA.122.039649. Epub 2022 Sep 6.
- Hong JM, Choi MH, Sohn SI, Hwang YH, Ahn SH, Lee YB, Shin DI, Chamorro A, Choi DW; on the behalf of the SONIC investigators. Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial. Trials. 2018 Jul 13;19(1):375. doi: 10.1186/s13063-018-2746-9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Salicylates
Other Study ID Numbers
- Neu2000KWL-P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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