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

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

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 Overview

• Status: Recruiting
• Conditions: Post Stroke Epilepsy
• Intervention / Treatment: Drug: idebenone 30 mg for 14 days; Drug: idebenone 30 mg for 3 months

• Study Type: Interventional
• Enrollment (Estimated): 2700
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Feng, PhD; Phone Number: 86-13873123853; Email: fenglihx@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital, Central South University
      • Contact: Li Feng, PhD; Phone Number: 86-13873123853; Email: fenglihx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	At the time of enrollment
The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	24 weeks after enrollment
The proportion of patients with epilepsy after stroke	Count the number of people with post-stroke epilepsy	48 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: idebenone; post-stroke epilepsy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Ubiquinone; Idebenone
• Other Study ID Numbers: 202306124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No