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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987397
Enrollment
2700
Registered
2023-08-14
Start date
2023-07-05
Completion date
2025-12-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Stroke Epilepsy

Keywords

post-stroke epilepsy, idebenone

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.

Interventions

DRUGidebenone 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.

DRUGidebenone 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).

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients with epilepsy after strokeAt the time of enrollmentCount the number of people with post-stroke epilepsy

Secondary

MeasureTime frameDescription
National Institutes of Health Stroke Scale (NIHSS)At the time of enrollmentThe 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)At the time of enrollmentThe minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
Hamilton Depression Scale (HAMD)At the time of enrollmentThe minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
Pittsburgh sleep quality index (PSQI)At the time of enrollmentThe minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
Stroke specific quality of life scale (SS-QOL)At the time of enrollmentThe minimum value is 38, the maximum value is 190, the higher score indicates better quality of life

Countries

China

Contacts

Primary ContactLi Feng, PhD
fenglihx@163.com86-13873123853

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026