Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients

NCT06315231 | Recruiting Phase 2

• 1 other identifier: SIM0308-02-Y-2-201
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 21

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial. The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke. Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.

Conditions

Post-stroke Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.

  Until follow up 26 weeks or early termination

• Number of discontinuation/withdrawal patients

  Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.

  Until follow up 26 weeks or early termination

• The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.

  The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 24 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.

  Until follow up 24 weeks

Secondary Outcomes (7)

• The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group

  Week 12 and Week 24

• The changes of Mini-Mental State Examination (MMSE) score

  Week 12 and Week 24

• The changes of Montreal Cognitive Assessment (MoCA) scale

  Week 12 and Week 24

• The changes of MoCA subscales

  Week 12 and Week 24

• Modified Rankin Scale (mRS) scores

  Week 12 and Week 24

Study Arms (2)

Group of edaravone dexborneol sublingual tablet

EXPERIMENTAL

Patients will receive edaravone dexborneol sublingual tablet twice daily of 24 weeks.

Drug: Edaravone dexborneol sublingual tablet

Placebo

PLACEBO COMPARATOR

Patients will receive placebo twice daily of 24 weeks.

Drug: Placebo

Interventions

Edaravone dexborneol sublingual tablet DRUG

Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks

Group of edaravone dexborneol sublingual tablet

Placebo DRUG

Patients will receive one placebo twice daily for 24 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years and ≤ 80 years, male or female.
• Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
• The National Institutes of Stroke Scale score ≤ 20 points.
• Time from onset to obtained informed consent form is within 7 days (including 7 days).
• Presence of cognitive dysfunction at screening, i.e., MoCA scale score \< 22.
• Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.
• Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.
• female subjects of childbearing potential and male subjects whose female partners are of childbearing potential must be willing to and use contraception during the study treatment and within 30 days after the last dose of study drug and have no plans to donate sperm or eggs; female subjects of childbearing potential will have a negative pregnancy test;
• obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.

You may not qualify if:

• Presence of intracranial hemorrhagic disease confirmed by brain imaging.
• Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point.
• Transient ischemic attack (TIA).
• Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
• Poorly controlled diabetes (fasting blood glucose \>10mmol/L and/or HbA1c\>8%).
• Patients with contraindications to MRI imaging.
• For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
• Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.
• Patients who have been diagnosed with severe mental disorders prior to stroke.
• Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.
• Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo Biloba Tablets, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ).
• Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST \> 2.0 × ULN.
• Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine \> 1.5 × ULN.
• Thrombectomy or interventional therapy has been applied or planned after this episode.
• History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. Subjects with a diagnosis of malignancy after enrollment may continue to participate in the study or not at the discretion of the investigator and at the discretion of the subject;

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (21)

Taihe County People's Hospital

Fuyang, Anhui, China

RECRUITING

Hefei First People's Hospital

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The Second People's Hospital of Hefei

Hefei, Anhui, China

RECRUITING

Huangshan City People's Hospital

Huangshan City, Anhui, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Zhumadian Central Hospital

Zhumadian, Henan, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Liaoning Health Industry Group Bensteel General Hospital

Benxi, Liaoning, China

RECRUITING

The First Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

The First People's Hospital of Shenyang

Shenyang, Liaoning, China

RECRUITING

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

RECRUITING

Tai'an Central Hospital

Taian, Shandong, China

RECRUITING

Suining Central Hospital

Suining, Sichuan, China

RECRUITING

Dongyang People's Hospital

Dongyang, Zhejiang, China

RECRUITING

The First People's Hospital of Huzhou

Huzhou, Zhejiang, China

RECRUITING

Zhuji People's Hospital of Zhejiang Province

Zhuji, Zhejiang, China

RECRUITING

Central Study Contacts

Chunchen Huang, Doctor

CONTACT

+8618502113382; huangchunchen@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: March 11, 2024
• First Posted: March 18, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (21)