Post Stroke Epilepsy Clinical Trial
Official title:
Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy
According to the random number table, all patients were divided into short-term treatment group, long-term treatment group and non-intervention stroke control group according to the proportion of (1:1:1) epilepsy disease modifier idebenone. Patients in the short-term treatment group will take idebenone for a total course of 14 days (acute period) after stroke, and patients in the long-term treatment group will take idebenone for a total course of 3 months after stroke.
Status | Recruiting |
Enrollment | 2700 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients admitted to hospital within 24 hours of stroke symptoms and diagnosed with stroke (including cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, intracranial venous sinus thrombosis, etc.) after relevant examinations; - Able to cooperate with the inspection; - Sign the informed consent form. Exclusion Criteria: - History of epilepsy before stroke; - A history of serious comorbidities that may lead to seizures (including malignant tumors, specific autoimmune diseases, severe electrolyte abnormalities, end-stage renal disease, and severe head trauma); - Secondary stroke caused by head trauma or surgery; - Other patients that the researchers think need to be excluded. |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital, Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Xiangya Hospital of Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | At the time of enrollment | |
Primary | The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 24 weeks after enrollment | |
Primary | The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 48 weeks after enrollment | |
Secondary | National Institutes of Health Stroke Scale (NIHSS) | The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients | At the time of enrollment | |
Secondary | National Institutes of Health Stroke Scale (NIHSS) | The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients | 24 weeks after enrollment | |
Secondary | National Institutes of Health Stroke Scale (NIHSS) | The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients | 48 weeks after enrollment | |
Secondary | Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | At the time of enrollment | |
Secondary | Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | 24 weeks after enrollment | |
Secondary | Hamilton Anxiety Scale (HAMA) | The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety | 48 weeks after enrollment | |
Secondary | Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | At the time of enrollment | |
Secondary | Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | 24 weeks after enrollment | |
Secondary | Hamilton Depression Scale (HAMD) | The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression | 48 weeks after enrollment | |
Secondary | Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | At the time of enrollment | |
Secondary | Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | 24 weeks after enrollment | |
Secondary | Pittsburgh sleep quality index (PSQI) | The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality | 48 weeks after enrollment | |
Secondary | Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | At the time of enrollment | |
Secondary | Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | 24 weeks after enrollment | |
Secondary | Stroke specific quality of life scale (SS-QOL) | The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life | 48 weeks after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05864547 -
Predisposing Factors for Post-stroke Epilepsy
|
||
Enrolling by invitation |
NCT06108102 -
International Post-Stroke Epilepsy Research Repository
|
||
Recruiting |
NCT03848273 -
Post Stroke Epileptic Seizures Risk Forecast
|