Coenzyme Q10 as Adjunctive Therapy in Drug-Resistant Epilepsy (Q10-DRE)

April 12, 2026 updated by: National Cheng-Kung University Hospital

A Randomized, Double-Blind, Placebo-Controlled Trial of Coenzyme Q10 as Adjunctive Therapy in Patients With Drug-Resistant Epilepsy

This study evaluates the efficacy and safety of coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized, double-blind, placebo-controlled trial investigates coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.

Eligible participants will be randomly assigned to receive either coenzyme Q10 or matching placebo in addition to their stable baseline anti-seizure medications. Coenzyme Q10 will be administered orally at a dose of 200 mg per day for 12 weeks.

Participants will be followed prospectively with scheduled clinical assessments throughout the study period to evaluate treatment response and safety.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 20 to 80 years.
  • Diagnosed with drug-resistant epilepsy.
  • Receiving stable anti-seizure medications for at least 4 weeks prior to enrollment.
  • Able to provide informed consent.
  • Willing and able to maintain seizure diaries throughout the study period.

Exclusion Criteria:

  • History of progressive neurological disease.
  • Severe systemic illness (e.g., uncontrolled cardiovascular, hepatic, or renal disease).
  • Use of coenzyme Q10 or other mitochondrial supplements within 4 weeks prior to enrollment.
  • Pregnancy or breastfeeding.
  • Known allergy or hypersensitivity to coenzyme Q10.
  • Participation in another clinical trial within the past 3 months.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coenzyme Q10
Participants in this arm received oral coenzyme Q10 supplementation at a dose of 200 mg per day in addition to their stable baseline anti-seizure medications. The supplementation was administered daily for 12 weeks.
Dietary supplement: coenzyme Q10
Coenzyme Q10 administered orally as an adjunct to baseline anti-seizure medications for 12 weeks.
Other Names:
  • Dietary Supplement
Placebo Comparator: Placebo
Matching placebo capsules administered orally once daily for 12 weeks.
Dietary supplement: Placebo
Matching placebo capsules administered orally once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in seizure frequency (seizures per month)
Time Frame: Baseline and 12 weeks
Seizure frequency will be assessed using patient seizure diaries. The number of seizures per month will be calculated and compared between baseline and 12 weeks.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function assessed by the Cognitive Abilities Screening Instrument (CASI; score range 0-100, higher scores indicate better cognitive function)
Time Frame: Baseline and 12 weeks
Cognitive function will be assessed using the Cognitive Abilities Screening Instrument (CASI). Total scores range from 0 to 100, with higher scores indicating better cognitive function.
Baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

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)

February 7, 2023

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-110-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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