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

Phase 4

Recruiting

• Conditions: Post Stroke Epilepsy
• Interventions: Drug: idebenone 30 mg for 3 months; Drug: idebenone 30 mg for 14 days

• Registration Number: NCT05987397
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-05
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Idebenone long-term treatment group	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.
Group A: Idebenone short-term treatment group	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).

Primary Outcome Measures

Name	Time	Method
The proportion of patients with epilepsy after stroke	48 weeks after enrollment	Count the number of people with post-stroke epilepsy

Secondary Outcome Measures

Name	Time	Method
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)	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)	48 weeks after enrollment	The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
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
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

Trial Locations

Locations (1)

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China