Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy

Conditions
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Post Stroke Epilepsy

Intervention / Treatment
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* Drug: idebenone 30 mg for 14 days
* Drug: idebenone 30 mg for 3 months


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Idebenone short-term treatment group<br>The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). | Drug: idebenone 30 mg for 14 days<br>* The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).<br>|
| Experimental: Group B: Idebenone long-term treatment group<br>The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. | Drug: idebenone 30 mg for 3 months<br>* The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | At the time of enrollment | 
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 24 weeks after enrollment | 
| The proportion of patients with epilepsy after stroke | Count the number of people with post-stroke epilepsy | 48 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-stroke epilepsy, idebenone