NCT05987397

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

July 19, 2023

Last Update Submit

August 3, 2023

Conditions

Post Stroke Epilepsy

Keywords

post-stroke epilepsyidebenone

Outcome Measures

Primary Outcomes (3)

  • The proportion of patients with epilepsy after stroke

    Count the number of people with post-stroke epilepsy

    At the time of enrollment

  • The proportion of patients with epilepsy after stroke

    Count the number of people with post-stroke epilepsy

    24 weeks after enrollment

  • The proportion of patients with epilepsy after stroke

    Count the number of people with post-stroke epilepsy

    48 weeks after enrollment

Secondary Outcomes (15)

  • National Institutes of Health Stroke Scale (NIHSS)

    At the time of enrollment

  • National Institutes of Health Stroke Scale (NIHSS)

    24 weeks after enrollment

  • National Institutes of Health Stroke Scale (NIHSS)

    48 weeks after enrollment

  • Hamilton Anxiety Scale (HAMA)

    At the time of enrollment

  • Hamilton Anxiety Scale (HAMA)

    24 weeks after enrollment

  • +10 more secondary outcomes

Study Arms (2)

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).

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.

Drug: idebenone 30 mg for 3 months

Interventions

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).

Group A: Idebenone short-term treatment group
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.

Group B: Idebenone long-term treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Interventions

idebenone

Central Study Contacts

Li Feng, PhD

CONTACT

86-13873123853fenglihx@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Vice Director of Neurology Teaching and Research Office

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 14, 2023

Study Start

July 5, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 14, 2023

Record last verified: 2023-07

Locations

CN(1)