Coenzyme Q10 as Adjunctive Therapy in Drug-Resistant Epilepsy

NCT07537283 | Completed

• 1 other identifier: A-BR-110-050
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Drugs Resistance

Keywords

Coenzyme Q10; Q10; Drug-resistant epilepsy; Seizure frequency; Cognitive function; Antiseizure medication; Valproate

Outcome Measures

Primary Outcomes (1)

• Change in seizure frequency (seizures per month)

  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 Outcomes (1)

• Change in cognitive function assessed by the Cognitive Abilities Screening Instrument (CASI; score range 0-100, higher scores indicate better cognitive function)

  Baseline and 12 weeks

Study Arms (2)

Coenzyme Q10

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Matching placebo capsules administered orally once daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

coenzyme Q10 DIETARY_SUPPLEMENT

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

Also known as: Dietary Supplement

Coenzyme Q10

Placebo DIETARY_SUPPLEMENT

Matching placebo capsules administered orally once daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Interventions

coenzyme Q10; Dietary Supplements

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors are blinded to group assignment. Placebo capsules are identical in appearance to coenzyme Q10 to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: February 7, 2023
• Primary Completion: September 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)