Coenzyme Q10 as Adjunctive Therapy in Drug-Resistant Epilepsy

National Cheng-Kung University Hospital39 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Epilepsy Drugs Resistance

Interventions

coenzyme Q10DIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Matching placebo capsules administered orally once daily for 12 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

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

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.

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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