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New treatment option for Stroke
Official title Effect of Butyphthalide on Cognitive Level Change After Cerebral Vascular Event-a Randomized Control Trial (Be-CLEVER)
ClinicalTrials.gov ID: NCT05976152
What this study is testing
What is dl-3-butylphthalide?
dl-3-butylphthalide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for stroke.
Also referred to as DL-3-n-butylphthalide (NBP).
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
- Post-stroke cognitive impairment (PSCI) refers to a clinical syndrome characterized by cognitive impairment that occurs after a stroke event and persists for at least 24 weeks. Due to the early recovery of conditions such as delirium and transient cognitive impairment after stroke, the diagnosis of PSCI often requires cognitive assessment at 12 to 24 weeks post-stroke to determine the severity of cognitive impairment.
- Phase 3: a large, late-stage study
- 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 60 and older
You may be able to join if
- First stage:
- Acute ischemic stroke (AIS) symptom onset within 14 days Signs and symptoms consistent with the diagnosis of an acute ischemic stroke by CT/MRI.
- Age \>= 60 years，
- Baseline NIHSS 3-18.
- Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations
You likely can't join if
- First stage:
- Patients who had been diagnosed with dementia prior to stroke
- Other related factors affecting cognitive function: central nervous system infection, neurodegenerative diseases, trauma, poisoning, intracranial...
- Other serious central nervous system diseases: Parkinson's disease, epilepsy, multiple sclerosis, motor neurone disease, immune-related...
- Serious mental illness: anxiety disorder, depression, delirium, schizophrenia, bipolar disorder, mental retardation, which is diagnosed or controlled...
- Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
See the full eligibility criteria
- First stage:
- Acute ischemic stroke (AIS) symptom onset within 14 days Signs and symptoms consistent with the diagnosis of an acute ischemic stroke by CT/MRI.
- Age \>= 60 years，
- Baseline NIHSS 3-18.
- Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations
- Patient/legally authorized representative has signed the Informed Consent Form Second stage:
- Patient with stage I diagnosis of PSCI.
- Patient can complete questionnaire survey, physical examination, cranial MRI and other medical examinations.
- Patient/legally authorized representative has signed the Informed Consent Form
- First stage:
- Patients who had been diagnosed with dementia prior to stroke
- Other related factors affecting cognitive function: central nervous system infection, neurodegenerative diseases, trauma, poisoning, intracranial space occupying lesions, metabolic diseases, etc.
- Other serious central nervous system diseases: Parkinson's disease, epilepsy, multiple sclerosis, motor neurone disease, immune-related encephalomyelopathy, etc.
- Serious mental illness: anxiety disorder, depression, delirium, schizophrenia, bipolar disorder, mental retardation, which is diagnosed or controlled by medication.
- Uncorrectable visual and hearing impairments and inability to complete neuropsychological tests
- Severe liver and kidney dysfunction
- The presence of a malignant tumor or other serious/life-threatening disease that could cause the subject's death within 12 months.
- Current known alcohol or illicit drug abuse or dependence
- Patients undergoing thrombectomy, thrombolysis, carotid endarterectomy, or other surgical procedures during the acute infarction.
- Using cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) receptor antagonists, or Sodium oligomannate (GV-971).
- Allergic to any component of butylphthalein
- Pregnancy or lactation, have the possibility of becoming pregnant, and who plan to become pregnant
- Participants in other treatment clinical trials
- MRI contraindications (e.g., claustrophobia, hypersensitivity to contrast media, etc.) Second stage:
- During the first phase of follow-up, participants' compliance was poor, with study medication compliance less than 80% or greater than 120%; Follow-up was less than 24 weeks or did not complete the follow-up within the...
- Recurrent stroke in the first stage
The study team makes the final eligibility decision.
Where it's taking place
- Dandong, Liaoning, 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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dandong, Liaoning, China. 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.