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

NCT ID: NCT05987397

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Stroke Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

idebenone 30 mg for 14 days

Intervention Type DRUG

The 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

The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.

Group Type EXPERIMENTAL

idebenone 30 mg for 3 months

Intervention Type DRUG

The patient will be treated with oral idebenone 30 mg three times a day after stroke for a total course of 3 months.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Li Feng, MD, PhD

Associate Professor Vice Director of Neurology Teaching and Research Office

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Feng, PhD

Role: CONTACT

86-13873123853

Facility Contacts

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Li Feng, PhD

Role: primary

86-13873123853

Other Identifiers

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202306124

Identifier Type: -

Identifier Source: org_study_id

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