Clinical trial NCT05987397: Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy
Official title: Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Stroke Epilepsy
Keywords: post-stroke epilepsy
idebenone
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The proportion of patients with epilepsy after stroke
timeFrame: At the time of enrollment
measure: The proportion of patients with epilepsy after stroke
timeFrame: 24 weeks after enrollment
measure: The proportion of patients with epilepsy after stroke
timeFrame: 48 weeks after enrollment
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At the time of enrollment
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 weeks after enrollment
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 48 weeks after enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: At the time of enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 24 weeks after enrollment
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 48 weeks after enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: At the time of enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: 24 weeks after enrollment
measure: Hamilton Depression Scale (HAMD)
timeFrame: 48 weeks after enrollment
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: At the time of enrollment
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 24 weeks after enrollment
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 48 weeks after enrollment
measure: Stroke specific quality of life scale (SS-QOL)
timeFrame: At the time of enrollment
measure: Stroke specific quality of life scale (SS-QOL)
timeFrame: 24 weeks after enrollment
measure: Stroke specific quality of life scale (SS-QOL)
timeFrame: 48 weeks after enrollment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: