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

Post-stroke Cognitive Impairment Clinical Trial

Official title:

Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315231
• Other study ID #: SIM0308-02-Y-2-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 8, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2024
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Chunchen Huang, Doctor
• Phone: +8618502113382
• Email: huangchunchen[@]simcere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 12 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 40 years and = 80 years, male or female.

2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score = 1prior to stroke onset).

3. The National Institutes of Stroke Scale score = 20 points.

4. Time from onset to obtained informed consent form is within 7 days (including 7 days).

5. Presence of cognitive dysfunction at screening, i.e., MoCA scale score < 22.

6. Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.

7. Education level: primary school or above, and can complete the cognitive function test requiredper investigator's judgement.

Exclusion Criteria:

1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.

2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1 point.

3. Transient ischemic attack (TIA).

4. Systolic blood pressure = 180 mmHg or diastolic blood pressure = 120 mmHg after blood pressure control.

5. Poorly controlled diabetes (fasting blood glucose >10mmol/L and/or HbA1c>8%).

6. Patients with contraindications to MRI imaging.

7. Patients with contraindications for EEG examination.

8. 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.

9. Patients who have been diagnosed with severe mental disorders prior to stroke.

10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.

11. 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 preparations, oxiracetam, aniracetam, piracetam,nicergoline, Lecanemab, Donanemab, Aducanemab, etc. ).

12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 × ULN.

13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine > 1.5 × ULN.

14. Thrombectomy or interventional therapy has been applied or planned after this episode.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Ischemic Stroke
• Post-stroke Cognitive Impairment
• Stroke

Intervention

Drug:
• Edaravone dexborneol sublingual tablet
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 12 weeks
• Placebo
Patients will receive one placebo twice daily for 12 weeks

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	The First Affiliated Hospital of USTC Anhui Provincial Hospital	Hefei	Anhui
China	The First People's Hospital of Huzhou	Huzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.	Until follow up 14 weeks or early termination
Primary	Number of discontinuation/withdrawal patients	Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.	Until follow up 14 weeks or early termination
Primary	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 12 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 12 weeks
Secondary	The incidence of Post Stroke Cognitive Impairment(PSCI )in each group	The incidence of PSCI in each group at week 12 of treatment, defined as Proportion of patients with MoCA score <22	Week 12
Secondary	The changes of Mini-Mental State Examination (MMSE) score	Mini-Mental State Examination (MMSE) at the 12th week of treatment (MMSE) score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.	Week 12
Secondary	The changes of Montreal Cognitive Assessment (MoCA) scale	Montreal Cognitive Assessment at the 12th week of treatment (MoCA) scale score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.	Week 12
Secondary	The changes of MoCA subscales	MoCA subscales (including visuospatial and execution) at week 12 of treatment Function, naming, delayed recall, attention, language, abstraction, Orientation 7 subitems) from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.	Week 12
Secondary	Modified Rankin Scale (mRS) scores	Modified Rankin Scale (mRS) scores at 12 weeks of treatment. The minimum score is 0 and maximum score is 5 and the higher scores means the worse outcome.	Week 12
Secondary	The changes of National Institutes of Health Stroke Scale	National Institutes of Health Stroke Scale at 4 and 12 weeks of treatment (NIHSS) score changes from baseline. The minimum score is 0 and maximum score is 42 and the higher scores means the worse outcome.	Week 4 and Week 12