EpilepsyQ10-DRENCT07537283
Coenzyme Q10 as Adjunctive Therapy in Drug-Resistant Epilepsy
A study testing coenzyme Q10 in people with Epilepsy and Drugs Resistance, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study evaluates the efficacy and safety of coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Epilepsy, Drugs Resistance
- What is being tested?
- coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Feb 2023to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Coenzyme Q10 as Adjunctive Therapy in Patients With Drug-Resistant Epilepsy
This study evaluates the efficacy and safety of coenzyme Q10 supplementation as adjunctive therapy in patients with drug-resistant epilepsy.
Read the 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.
- Conditions
- Epilepsy, Drugs Resistance
- Being tested
- coenzyme Q10, Placebo
- Keywords
- Coenzyme Q10, Q10, Drug-resistant epilepsy, Seizure frequency, Cognitive function, Antiseizure medication, Valproate
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coenzyme Q10Dietary supplement
Also called Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: coenzyme Q10 |
| Placebo | Placebo comparator | Matching placebo capsules administered orally once daily for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start7 Feb 2023
- Primary completion28 Sep 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537283
- Sponsor's protocol ID
- A-BR-110-050
- Acronym
- Q10-DRE
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Coenzyme Q10 as Adjunctive Therapy in Patients With Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07537283
- Acronym / sponsor ID
- Q10-DRE / A-BR-110-050
- Conditions
- Epilepsy, Drugs Resistance
- Keywords
- Coenzyme Q10, Q10, Drug-resistant epilepsy, Seizure frequency, Cognitive function, Antiseizure medication, Valproate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Experimental | Dietary Supplement: coenzyme Q10Participants 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 | Dietary Supplement: PlaceboMatching placebo capsules administered orally once daily for 12 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coenzyme Q10Also: Dietary SupplementCoenzyme Q10 administered orally as an adjunct to baseline anti-seizure medications for 12 weeks. | Dietary supplement | Coenzyme Q10 |
| PlaceboMatching placebo capsules administered orally once daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and institutional regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coenzyme Q10 in people with Epilepsy and Drugs Resistance, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seizure frequency (seizures per month) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.