Post Stroke EpilepsyPhase 4NCT05987397
Exploring the Preventive Effect of Mitochondrial Protective Agent Idebenone on Post-stroke Epilepsy
A Phase 4 study testing idebenone 30 mg for 14 days and idebenone 30 mg for 3 months in people with Post Stroke Epilepsy, run by Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Stroke Epilepsy
- What is being tested?
- idebenone 30 mg for 14 days and idebenone 30 mg for 3 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Li Feng, PhD, 86-13873123853, fenglihx@163.com
About this study
Official title: 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.
- Conditions
- Post Stroke Epilepsy
- Being tested
- idebenone 30 mg for 14 days, idebenone 30 mg for 3 months
- Keywords
- post-stroke epilepsy, idebenone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Idebenone short-term treatment group | Experimental | The patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). Receives: Drug: idebenone 30 mg for 14 days |
| Group B: Idebenone long-term treatment group | Experimental | The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. Receives: Drug: idebenone 30 mg for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
Measured: At the time of enrollment
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
Measured: 24 weeks after enrollment
The proportion of patients with epilepsy after stroke
Count the number of people with post-stroke epilepsy
Measured: 48 weeks after enrollment
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke EpilepsyStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Feng, MD, PhD, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987397
- Sponsor's protocol ID
- 202306124
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy
- ClinicalTrials.gov ID
- NCT05987397
- Acronym / sponsor ID
- 202306124
- Conditions
- Post Stroke Epilepsy
- Keywords
- post-stroke epilepsy, idebenone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Idebenone short-term treatment group | Experimental | Drug: idebenone 30 mg for 14 daysThe patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). |
| Group B: Idebenone long-term treatment group | Experimental | Drug: idebenone 30 mg for 3 monthsThe patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| idebenone 30 mg for 14 daysThe patient received oral idebenone 30 mg three times a day after stroke for a total course of 14 days (acute phase). | Drug | Group A: Idebenone short-term treatment group |
| idebenone 30 mg for 3 monthsThe patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months. | Drug | Group B: Idebenone long-term treatment group |
Primary outcome
The proportion of patients with epilepsy after stroke
Time frame: At the time of enrollment
Count the number of people with post-stroke epilepsy
The proportion of patients with epilepsy after stroke
Time frame: 24 weeks after enrollment
Count the number of people with post-stroke epilepsy
The proportion of patients with epilepsy after stroke
Time frame: 48 weeks after enrollment
Count the number of people with post-stroke epilepsy
15 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
Time frame: At the time of enrollment
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 weeks after enrollment
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 48 weeks after enrollment
Hamilton Anxiety Scale (HAMA)
Time frame: At the time of enrollment
Hamilton Anxiety Scale (HAMA)
Time frame: 24 weeks after enrollment
Hamilton Anxiety Scale (HAMA)
Time frame: 48 weeks after enrollment
Hamilton Depression Scale (HAMD)
Time frame: At the time of enrollment
Hamilton Depression Scale (HAMD)
Time frame: 24 weeks after enrollment
Hamilton Depression Scale (HAMD)
Time frame: 48 weeks after enrollment
Pittsburgh sleep quality index (PSQI)
Time frame: At the time of enrollment
Pittsburgh sleep quality index (PSQI)
Time frame: 24 weeks after enrollment
Pittsburgh sleep quality index (PSQI)
Time frame: 48 weeks after enrollment
Stroke specific quality of life scale (SS-QOL)
Time frame: At the time of enrollment
Stroke specific quality of life scale (SS-QOL)
Time frame: 24 weeks after enrollment
Stroke specific quality of life scale (SS-QOL)
Time frame: 48 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing idebenone 30 mg for 14 days and idebenone 30 mg for 3 months in people with Post Stroke Epilepsy, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Feng, PhD (86-13873123853, fenglihx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with epilepsy after stroke (time frame: At the time of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.