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

August 3, 2023 updated by: Li Feng, MD, PhD, Xiangya Hospital of Central South University

Clinical Multi-center Study of Mitochondrial Brain Protective Agent Idebenone in the Prevention of Post-stroke Epilepsy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Drug: 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).
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of patients with epilepsy after stroke
Time Frame: At the time of enrollment
Count the number of people with post-stroke epilepsy
At the time of enrollment
The proportion of patients with epilepsy after stroke
Time Frame: 24 weeks after enrollment
Count the number of people with post-stroke epilepsy
24 weeks after enrollment
The proportion of patients with epilepsy after stroke
Time Frame: 48 weeks after enrollment
Count the number of people with post-stroke epilepsy
48 weeks after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: At the time of enrollment
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
At the time of enrollment
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 24 weeks after enrollment
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
24 weeks after enrollment
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 48 weeks after enrollment
The minimum value is 0, the maximum value is 24, the higher score indicates the more severe neurological impairment in stroke patients
48 weeks after enrollment
Hamilton Anxiety Scale (HAMA)
Time Frame: At the time of enrollment
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
At the time of enrollment
Hamilton Anxiety Scale (HAMA)
Time Frame: 24 weeks after enrollment
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
24 weeks after enrollment
Hamilton Anxiety Scale (HAMA)
Time Frame: 48 weeks after enrollment
The minimum value is 0, the maximum value is 56, the higher score indicates a great likelihood of anxiety
48 weeks after enrollment
Hamilton Depression Scale (HAMD)
Time Frame: At the time of enrollment
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
At the time of enrollment
Hamilton Depression Scale (HAMD)
Time Frame: 24 weeks after enrollment
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
24 weeks after enrollment
Hamilton Depression Scale (HAMD)
Time Frame: 48 weeks after enrollment
The minimum value is 0, the maximum value is 77, the higher score indicates a great likelihood of depression
48 weeks after enrollment
Pittsburgh sleep quality index (PSQI)
Time Frame: At the time of enrollment
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
At the time of enrollment
Pittsburgh sleep quality index (PSQI)
Time Frame: 24 weeks after enrollment
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
24 weeks after enrollment
Pittsburgh sleep quality index (PSQI)
Time Frame: 48 weeks after enrollment
The minimum value is 0, the maximum value is 21, the higher score indicates poorer sleep quality
48 weeks after enrollment
Stroke specific quality of life scale (SS-QOL)
Time Frame: At the time of enrollment
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
At the time of enrollment
Stroke specific quality of life scale (SS-QOL)
Time Frame: 24 weeks after enrollment
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
24 weeks after enrollment
Stroke specific quality of life scale (SS-QOL)
Time Frame: 48 weeks after enrollment
The minimum value is 38, the maximum value is 190, the higher score indicates better quality of life
48 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202306124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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