Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke (SLEDAIS)

NCT07682922 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026-189-002
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial (SLEDAIS) involving 1,040 patients with acute ischemic stroke (AIS) who require inter-hospital transfer for potential endovascular therapy. The study aims to evaluate the efficacy and safety of sublingual Edaravone Dexborneol tablets administered in the ultra-early stage (within 6 hours of symptom onset) during the critical inter-hospital transfer window. Patients will be randomly assigned in a 1:1 ratio to receive either sublingual Edaravone Dexborneol (a loading dose of 4 tablets initially, followed by 1 tablet twice daily for 13 days) or a matching placebo. The primary efficacy endpoint is the functional outcome assessed by the modified Rankin Scale (mRS) score at 90 days. The primary safety endpoint is the mortality rate at 90 days. This study seeks to provide high-quality evidence for neuroprotection during the transfer period, potentially improving functional recovery for stroke patients.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Modified Rankin Scale (mRS) Score at 90 Days

  Functional outcome assessed by the modified Rankin Scale (mRS) at 90 days post-randomization. The mRS is an ordinal scale ranging from 0 (no symptoms) to 6 (death), used to evaluate the degree of disability or dependence in daily activities.

  90 days

• Mortality Rate at 90 Days

  All-cause mortality rate within 90 days post-randomization.

  90 days

Secondary Outcomes (9)

• Infarct Volume at 36 Hours

  36 hours

• NIHSS Score at Discharge

  5-7 days or discharge

• Proportion of Patients With mRS 0-1 at 90 Days

  90 days

• Proportion of Patients With mRS 0-2 at 90 Days

  90 days

• EQ-5D-5L Score at 90 Days

  90 days

Study Arms (2)

Edaravone Dexborneol Group

EXPERIMENTAL

Drug: Edaravone dexborneol sublingual tablet

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Edaravone dexborneol sublingual tablet DRUG

Edaravone Dexborneol is a novel neuroprotective agent combining edaravone (a free radical scavenger) and dexborneol (an anti-inflammatory component) in a 5:1 ratio. In this study, participants in the experimental group will receive a loading dose of 4 sublingual tablets (each containing edaravone 30mg + dexborneol 6mg, total: edaravone 120mg + dexborneol 24mg) within 10 minutes after randomization during inter-hospital transfer. From day 2 to day 14, participants will receive 1 tablet twice daily. The sublingual formulation dissolves within 5 minutes, allowing rapid absorption through the sublingual venous plexus and bypassing hepatic first-pass effect. This high initial loading dose aims to rapidly establish therapeutic concentrations before endovascular therapy to provide neuroprotection during the critical transfer window.

Edaravone Dexborneol Group

Placebo DRUG

Matching placebo sublingual tablets identical in appearance, smell, and packaging to the active drug. Participants will receive a loading dose of 4 placebo tablets (each containing 60μg dexborneol, a trace amount solely for maintaining blinding with no expected therapeutic effect) within 10 minutes after randomization. From day 2 to day 14, participants will receive 1 placebo tablet twice daily. The placebo is designed to be indistinguishable from Edaravone Dexborneol tablets to maintain the double-blind design.

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:

• Aged 18 to 80 years (inclusive).
• Time from last known normal to arrival at the first hospital is within 6 hours.
• Clinical and imaging diagnosis of acute ischemic stroke, with a Los Angeles Motor Scale (LAMS) score ≥ 4, or occlusion of the internal carotid artery, M1/M2 segment of the middle cerebral artery, V4 segment of the vertebral artery, or basilar artery confirmed by CTA/MRA at the first or target hospital.
• ASPECTS score ≥ 6 on non-contrast head CT at the first hospital.
• Clinically assessed as planned for immediate transfer to a target hospital for evaluation of endovascular therapy (final decision on whether to perform EVT is made by the neuro-interventionist at the target hospital based on imaging and clinical status).
• Written informed consent signed by the patient or their legal representative.

You may not qualify if:

• Allergy to contrast agents, nickel, titanium, or their alloys.
• Known allergy to dexborneol, edaravone, or excipients.
• Pre-stroke modified Rankin Scale (mRS) score ≥ 2.
• Patients receiving intravenous thrombolysis alone.
• Severe impairment of consciousness (e.g., GCS score \< 8) or inability to cooperate with sublingual administration.
• Severe hepatic or renal insufficiency (e.g., ALT/AST \> 3 times the upper limit of normal, Cr \> 2 times the upper limit of normal).
• Estimated inter-hospital transfer time \> 3 hours.
• Pregnant or lactating women.
• Arterial tortuosity and/or other arterial diseases where the thrombectomy device is expected to be unable to reach the target vessel.
• Brain tumors with mass effect on imaging (except small meningiomas).
• Currently participating in other drug clinical trials.
• History of neurological or psychiatric diseases that hinder the assessment of neurological function.
• Any late-stage disease with an expected life expectancy \< 6 months.

Sponsors & Collaborators

• Simcere Pharmaceutical Group Co., LTD: collaborator
• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Xinqiao Hospital and The Second Affiliated Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhongming Qiu, MD

CONTACT

+86 13236599269; qiuzhongmingdoctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)