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

Post Stroke Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987397
• Other study ID #: 202306124
• Status: Recruiting
• Phase: Phase 4
• Start date: July 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Xiangya Hospital of Central South University
• Contact: Li Feng, PhD
• Phone: 86-13873123853
• Email: fenglihx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Post Stroke Epilepsy
• Stroke

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	At the time of enrollment
Primary	The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	24 weeks after enrollment
Primary	The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	48 weeks after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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