Overview

Safety and Optimal Neuroprotection of neu2000 in Ischemic Stroke With Endovascular reCanalizion (SONIC)

Status:
Unknown status
Trial end date:
2018-12-30
Target enrollment:
0
Participant gender:
All
Summary
Efficacy and safety of Neu2000, a multi-target drug designed to prevent both NMDA receptor-mediated excitotoxicity and free radical toxicity, will be investigated in acute ischemic stroke patients receiving endovascular treatment to remove clot within 8 hours following stroke onset. Neu2000KWL will be administered before endovascular treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GNT Pharma
Treatments:
Salicylates
Criteria
Inclusion Criteria:

1. Adults ≥19 years

2. 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.

3. NIHSS scores on screening time point (admission) ≥ 8 points

4. 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

5. 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

6. Patients with ASPECTS on Brain CT without early imaging hyper-enhancement ≥ 6

7. Patients who spontaneously submitted a written informed consent to participation on
this clinical study

Exclusion Criteria:

1. a medical history of hypersensitivity against aspirin (salicylates), sulfasalazine or
(5-ASA) at screening.

2. 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.

3. 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

4. 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.

5. Patients who have contraindication to contrast media for brain imaging

6. Patients who are receiving renal replacement therapy such as dialysis, due to acute or
chronic renal failure, nephropathy, etc. at screening.

7. Patients who were diagnosed with cancer or received cancer therapy within 6 months at
screening or have recurrent or transitional cancer

8. Patients who show high body temperature of 38℃ or more or who need antibiotic therapy
due to medical opinion of infectious diseases at screening.

9. Patients who take pharmacotherapy due to liver diseases such as hepatitis, liver
cirrhosis etc. at screening.

10. 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.

11. 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.

12. Patients who were determined unsuitable for participation in this clinical study due
to other reasons.