Drugs Resistance, Epilepsy
Conditions
Keywords
Coenzyme Q10, Q10, Drug-resistant epilepsy, Seizure frequency, Cognitive function, Antiseizure medication, Valproate
Brief summary
This study evaluates the efficacy and safety of coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.
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.
Interventions
DIETARY_SUPPLEMENTcoenzyme Q10
Coenzyme Q10 administered orally as an adjunct to baseline anti-seizure medications for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Matching placebo capsules administered orally once daily for 12 weeks.
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcomes assessors are blinded to group assignment. Placebo capsules are identical in appearance to coenzyme Q10 to maintain blinding.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in seizure frequency (seizures per month) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Taiwan
Outcome results
None listed