Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: Idebenone short-term treatment group 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
The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
|
| Experimental: Group B: Idebenone long-term treatment group 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
The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
|
Outcome Measures
Primary Outcome Measures
- The proportion of patients with epilepsy after stroke [At the time of enrollment]
Count the number of people with post-stroke epilepsy
- The proportion of patients with epilepsy after stroke [24 weeks after enrollment]
Count the number of people with post-stroke epilepsy
- The proportion of patients with epilepsy after stroke [48 weeks after enrollment]
Count the number of people with post-stroke epilepsy
Secondary Outcome Measures
- National Institutes of Health Stroke Scale (NIHSS) [At the time of enrollment]
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
- National Institutes of Health Stroke Scale (NIHSS) [24 weeks after enrollment]
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
- National Institutes of Health Stroke Scale (NIHSS) [48 weeks after enrollment]
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
- Hamilton Anxiety Scale (HAMA) [At the time of enrollment]
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
- Hamilton Anxiety Scale (HAMA) [24 weeks after enrollment]
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
- Hamilton Anxiety Scale (HAMA) [48 weeks after enrollment]
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
- Hamilton Depression Scale (HAMD) [At the time of enrollment]
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
- Hamilton Depression Scale (HAMD) [24 weeks after enrollment]
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
- Hamilton Depression Scale (HAMD) [48 weeks after enrollment]
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
- Pittsburgh sleep quality index (PSQI) [At the time of enrollment]
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
- Pittsburgh sleep quality index (PSQI) [24 weeks after enrollment]
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
- Pittsburgh sleep quality index (PSQI) [48 weeks after enrollment]
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
- Stroke specific quality of life scale (SS-QOL) [At the time of enrollment]
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
- Stroke specific quality of life scale (SS-QOL) [24 weeks after enrollment]
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
- Stroke specific quality of life scale (SS-QOL) [48 weeks after enrollment]
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya Hospital, Central South University | Changsha | Hunan | China | 410008 |
Sponsors and Collaborators
- Xiangya Hospital of Central South University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202306124