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

Xiangya Hospital of Central South University2,700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,700

Conditions

Post Stroke Epilepsy

Interventions

idebenone 30 mg for 14 daysDRUG

The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).

idebenone 30 mg for 3 monthsDRUG

The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

The proportion of patients with epilepsy after stroke

Count the number of people with post-stroke epilepsy

Time frame: At the time of enrollment

The proportion of patients with epilepsy after stroke

Count the number of people with post-stroke epilepsy

Time frame: 24 weeks after enrollment

The proportion of patients with epilepsy after stroke

Count the number of people with post-stroke epilepsy

Time frame: 48 weeks after enrollment

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At the time of enrollment

Central Contacts

Li Feng, PhD

CONTACT

86-13873123853 fenglihx@163.com

Data from ClinicalTrials.gov

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