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

Last updated: August 3, 2023
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

4

Condition

Stroke

Epilepsy

Cerebral Ischemia

Treatment

idebenone 30 mg for 14 days

idebenone 30 mg for 3 months

Clinical Study ID

NCT05987397
202306124
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients admitted to hospital within 24 hours of stroke symptoms and diagnosed withstroke (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

Exclusion Criteria:

  • History of epilepsy before stroke;
  • A history of serious comorbidities that may lead to seizures (including malignanttumors, specific autoimmune diseases, severe electrolyte abnormalities, end-stagerenal disease, and severe head trauma);
  • Secondary stroke caused by head trauma or surgery;
  • Other patients that the researchers think need to be excluded.

Study Design

Total Participants: 2700
Treatment Group(s): 2
Primary Treatment: idebenone 30 mg for 14 days
Phase: 4
Study Start date:
July 05, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

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