Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke

NCT04950920 | Completed Phase 3

• 1 other identifier: D2020185
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 1

Brief Summary

At present, the treatment of acute ischemic stroke includes intravenous thrombolysis, intravascular interventional therapy (including arterial thrombolysis, mechanical thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2 sublingual tablet is an innovative drug developed by Yantai yinuoyi Biomedical Technology Co., Ltd. with independent intellectual property rights. This product is a free radical scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block the pathological change process caused by cerebral ischemia from two ways, and play a synergistic therapeutic role in cerebral ischemia injury.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• mRS score ≤ 1

  Whether patients with mRS(Modified Rankin Scale) score ≤ 1. Used to calculate the proportion of patients with mRS score ≤ 1.

  90 days after treatment initiation

Secondary Outcomes (6)

• patients' mRS score

  90 days after treatment initiation

• Good functional outcome

  90 days after treatment initiation

• change of NIHSS score

  14 after treatment initiation

• NIHSS score≤1 on 14 day

  14 after treatment initiation

• NIHSS score≤1 on 30 day

  30 after treatment initiation

Study Arms (2)

Y-2 sublingual test group

EXPERIMENTAL

Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg.

Drug: Y-2 sublingual tablets

placebo group

SHAM COMPARATOR

60 μg d-borneol

Drug: d-borneol

Interventions

Y-2 sublingual tablets DRUG

30mg Edaravone+6mg d-borneo OR， Bid

Y-2 sublingual test group

d-borneol DRUG

60 μg d-borneol OR， Bid

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who meet all of the following requirements:
• Age ≥ 18 years old and ≤ 80 years old, regardless of gender;
• After the onset of the disease, the National Institutes of Stroke Scale score: 6 ≤ NIHSS ≤ 20, and the sum of the fifth upper limb score and the sixth lower limb score was ≥2;
• The onset time is within 48 hours (including 48 hours);
• Patients diagnosed as ischemic stroke according to "key points for diagnosis of all kinds of major cerebrovascular diseases in China 2019", with good prognosis after the first attack or the last attack (MRS score ≤ 1 before this attack);
• The informed consent approved by the ethics committee was voluntarily signed by the patient or his legal representative.

You may not qualify if:

• Those who meet any of the following items:
• Severe disturbance of consciousness: the item score of La consciousness level of NIHSS was more than 1;
• Transient ischemic attack (TIA);
• Systolic blood pressure was still higher than 220mmhg or diastolic blood pressure was higher than 120mmhg after blood pressure control;
• Patients with severe mental disorders and dementia;
• Severe active liver diseases have been diagnosed, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Or ALT or AST \> 2.0 × ULN;
• Severe active kidney disease and renal insufficiency have been diagnosed; Or serum creatinine \> 1.5 × ULN;
• After the onset of the disease, the drugs with neuroprotective effect in the manual have been used;
• Embolectomy or interventional therapy has been used or planned after the onset of the disease;
• Complicated with malignant tumor or undergoing anti-tumor treatment; For the subjects diagnosed with malignant tumor after enrollment, whether to continue to participate in the study can be judged by the researcher and the willingness of the subjects;
• Suffering from severe systemic diseases, the estimated survival time is less than 90 days;
• Allergic to d-borneol or edaravone or excipients;
• Patients during pregnancy, lactation and planned pregnancy;
• Major operation history within 4 weeks before enrollment;
• Have participated in other clinical studies or are participating in other clinical studies within 30 days before randomization;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijin, China

Location

Related Publications (2)

• Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.

  PMID: 38372981 DERIVED

• Fu Y, Tang R, Chen R, Wang A, Ren J, Zhu S, Feng X, Fan D. Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):90-95. doi: 10.1136/svn-2022-002014.

  PMID: 37308251 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dongsheng Fan, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: June 28, 2021
• Primary Completion: August 10, 2022
• Study Completion: November 14, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)