Using idebenone to prevent epilepsy after a stroke
Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy
This study is testing if a medication called idebenone can help prevent epilepsy in people who have had a stroke.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2700 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05987397 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of idebenone, a mitochondrial protective agent, in preventing post-stroke epilepsy. Patients who have experienced a stroke will be randomly assigned to receive idebenone for either a short-term period of 14 days or a long-term period of 3 months, while a control group will not receive the intervention. The study aims to assess whether idebenone can reduce the incidence of epilepsy following a stroke. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are patients who have been admitted to the hospital within 24 hours of stroke symptoms and diagnosed with a stroke.
Not a fit: Patients with a history of epilepsy prior to the stroke or serious comorbidities that may lead to seizures will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing epilepsy in stroke survivors.
How similar studies have performed: While the use of idebenone is being explored in this context, similar studies have not been widely reported, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Feng, PhD
- Email: fenglihx@163.com
- Phone: 86-13873123853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.