Back to resultsExploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy
Primary Purpose
Post Stroke Epilepsy
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
idebenone 30 mg for 14 days
idebenone 30 mg for 3 months
Sponsored by
About this trial
This is an interventional treatment trial for Post Stroke Epilepsy focused on measuring post-stroke epilepsy, idebenone
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.
Sites / Locations
- Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A: Idebenone short-term treatment group
Group B: Idebenone long-term treatment group
Arm Description
The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
Outcomes
Primary Outcome Measures
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
Secondary Outcome Measures
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
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
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
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Hamilton Anxiety Scale (HAMA)
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Hamilton Depression Scale (HAMD)
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Pittsburgh sleep quality index (PSQI)
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Pittsburgh sleep quality index (PSQI)
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Pittsburgh sleep quality index (PSQI)
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
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
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
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
Full Information
NCT ID
NCT05987397
First Posted
July 19, 2023
Last Updated
August 3, 2023
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05987397
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Epilepsy
Keywords
post-stroke epilepsy, idebenone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Idebenone short-term treatment group
Arm Type
Experimental
Arm Description
The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
Arm Title
Group B: Idebenone long-term treatment group
Arm Type
Experimental
Arm Description
The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
Intervention Type
Drug
Intervention Name(s)
idebenone 30 mg for 14 days
Intervention Description
The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase).
Intervention Type
Drug
Intervention Name(s)
idebenone 30 mg for 3 months
Intervention Description
The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.
Primary Outcome Measure Information:
Title
The proportion of patients with epilepsy after stroke
Description
Count the number of people with post-stroke epilepsy
Time Frame
At the time of enrollment
Title
The proportion of patients with epilepsy after stroke
Description
Count the number of people with post-stroke epilepsy
Time Frame
24 weeks after enrollment
Title
The proportion of patients with epilepsy after stroke
Description
Count the number of people with post-stroke epilepsy
Time Frame
48 weeks after enrollment
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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
Title
Hamilton Anxiety Scale (HAMA)
Description
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
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Time Frame
24 weeks after enrollment
Title
Hamilton Anxiety Scale (HAMA)
Description
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Time Frame
48 weeks after enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Time Frame
At the time of enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Time Frame
24 weeks after enrollment
Title
Hamilton Depression Scale (HAMD)
Description
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Time Frame
48 weeks after enrollment
Title
Pittsburgh sleep quality index (PSQI)
Description
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Time Frame
At the time of enrollment
Title
Pittsburgh sleep quality index (PSQI)
Description
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Time Frame
24 weeks after enrollment
Title
Pittsburgh sleep quality index (PSQI)
Description
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Time Frame
48 weeks after enrollment
Title
Stroke specific quality of life scale (SS-QOL)
Description
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
Time Frame
At the time of enrollment
Title
Stroke specific quality of life scale (SS-QOL)
Description
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
Time Frame
24 weeks after enrollment
Title
Stroke specific quality of life scale (SS-QOL)
Description
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
Time Frame
48 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Feng, PhD
Phone
86-13873123853
Email
fenglihx@163.com
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Feng, PhD
Phone
86-13873123853
Email
fenglihx@163.com
12. IPD Sharing Statement
Learn more about this trial
Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy
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