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New treatment option for Post-stroke Cognitive Impairment
Official title Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
ClinicalTrials.gov ID: NCT06315231
What this study is testing
What is Edaravone dexborneol sublingual tablet?
Edaravone dexborneol sublingual tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for post-stroke cognitive impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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.
You likely can't join 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.
See the full eligibility criteria
- 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 people of childbearing potential and male people 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...
- obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.
- 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 people 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...
- 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...
- 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 treatment therapy has been applied or planned after this episode.
- History of malignancy; except for people with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. people with a diagnosis of malignancy after enrollment may continue...
- Suffering from a severe systemic disease with an expected survival period of \<1 year;
- hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);
- pregnancy, lactation, and patients planning pregnancy;
- history of major surgery within 4 weeks prior to enrollment;
- participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;
- in the opinion of the investigator, not suitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Huangshan City, Anhui, China
- Guangzhou, Guangdong, China
- Wuzhou, Guangxi, China
- Shijiazhuang, Hebei, China
- Zhumadian, Henan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Benxi, Liaoning, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Jining, Shandong, China
- Liaocheng, Shandong, China
- Taian, Shandong, China
- Suining, Sichuan, China
- Dongyang, Zhejiang, China
- Huzhou, Zhejiang, China
- Zhuji, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuyang, Anhui, China; Hefei, Anhui, China; Huangshan City, Anhui, China; Guangzhou, Guangdong, China; Wuzhou, Guangxi, China; Shijiazhuang, Hebei, China and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.