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Completed

NCT Number: NCT07537283

Coenzyme Q10 as Adjunctive Therapy in Drug-Resistant Epilepsy

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coenzyme Q10

Dietary Supplement

Coenzyme Q10 administered orally as an adjunct to baseline anti-seizure medications for 12 weeks.

Other names: Dietary Supplement

Placebo

Dietary Supplement

Matching placebo capsules administered orally once daily for 12 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Acronym: Q10-DRE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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