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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Matching placebo capsules administered orally once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coenzyme Q10 | Dietary Supplement | Coenzyme Q10 administered orally as an adjunct to baseline anti-seizure medications for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Participants, care providers, investigators, and outcomes assessors are blinded to group assignment. Placebo capsules are identical in appearance to coenzyme Q10 to maintain blinding.
| Placebo | Dietary Supplement | Matching placebo capsules administered orally once daily for 12 weeks. |
|