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StrokePhase 3NCT04950920

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

A Phase 3 study testing Y-2 sublingual tablets and d-borneol in people with Stroke, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Y-2 sublingual tablets and d-borneol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
914 participants
Where
1 siteChina
Study dates
28 Jun 2021to 14 Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • 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.

Who cannot join

  • -
  • Those who meet any of the following items:
  • Intracranial hemorrhagic diseases seen in head imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can judge whether it is suitable for inclusion;
  • 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;
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  • 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;
  • The researcher thinks that it is not suitable to participate in this clinical study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijin

Other trials in China

About this study

Official title: Phase III Clinical Trial of Y-2 Sublingual Tablet in the Treatment of Acute Ischemic Stroke - a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial

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.

Read the detailed description

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
Being tested
Y-2 sublingual tablets, d-borneol
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Y-2 sublingual tabletsDrug

    30mg Edaravone+6mg d-borneo OR， Bid

  • d-borneolDrug

    60 μg d-borneol OR， Bid

Study groups in NCT04950920
Study groupRoleWhat they receive
Y-2 sublingual test groupExperimentalY-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg.
Receives: Drug: Y-2 sublingual tablets
placebo groupSham comparator60 μg d-borneol
Receives: Drug: d-borneol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mRS score ≤ 1

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

    Measured: 90 days after treatment initiation

Secondary outcomes (6)

  1. patients' mRS score

    patients' modified Rankin score

    Measured: 90 days after treatment initiation

  2. Good functional outcome

    Whether patients with mRS score ≤ 2. Used to calculate the proportion of good functional outcome (mRS ≤2)

    Measured: 90 days after treatment initiation

  3. change of NIHSS score

    Change of NIHSS (National Institute of Health stroke scale) score from baseline to day 14 after randomization

    Measured: 14 after treatment initiation

  4. NIHSS score≤1 on 14 day

    Whether NIHSS (National Institute of Health stroke scale) score≤1 on 14 day. Used to calculate the proportion of NIHSS score≤1 on 14 day.

    Measured: 14 after treatment initiation

  5. NIHSS score≤1 on 30 day

    Whether NIHSS (National Institute of Health stroke scale) score≤1 on 30 day. Used to calculate the proportion of NIHSS score≤1 on 30 day.

    Measured: 30 after treatment initiation

  6. NIHSS score≤1 on 90 day

    Whether NIHSS (National Institute of Health stroke scale) score≤1 on 90 day. Used to calculate the proportion of NIHSS score≤1 on 90 day.

    Measured: 90 after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start28 Jun 2021
  3. Primary completion10 Aug 2022
  4. Study completion14 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
914 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950920
Sponsor's protocol ID
D2020185
Status last verified
Aug 2023
First submitted
27 Jun 2021
Last updated
22 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38372981

  • 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.

    PubMed 37308251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Y-2 sublingual tablets and d-borneol in people with Stroke, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mRS score ≤ 1 (time frame: 90 days after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04950920, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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