EpilepsyPhase 2NCT02899741
Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study
A Phase 2 study testing Omega-3 in people with Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Omega-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Nov 2018
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with medically intractable, focal or generalized, epilepsy: Patients with localization-related partial onset or generalized tonic/clonic seizure according to the International League Against Epilepsy (ILAE) can be included. Medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year.
- Seizure frequency criteria: three seizures per one month for recent 3 months before enrollment
- Seizure criteria: simple partial, complex partial, or tonic-clonic seizures
- Subjects with normal cognitive function: patients who can perform normal daily life. If not definite, enrollment will be done with K-MMSE score over 27.
Who cannot join
- Poor general medical condition: comorbid with heart, lung, liver diseases
- Patients who have history of pseudo-seizure
- Anti-epileptic drugs has been changed in recent one month.
- Chronic alcoholic
- Seizure count cannot be done since seizures occur successively.
- Allergy to fish
Show all 10Show fewer
- High risk of bleeding such as trauma or operation
- Liver function abnormality
- Pregnant or lactating women, or women who plans to have children
- Patients who have participated in the other clinical trial in recent one month
Trial locations and contacts
1 site in 1 country.
Kon Chu, MD, PhD contact
Tae-Joon Kim, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Kon Chu, Professor, stemcell.snu@gmail.com
Tae-Joon Kim, Fellow, dandy8123@gmail.com
About this study
The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.
Read the detailed description
This study will enroll total 30 patients with medically intractable epilepsy. The patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. After three months, Omega-3 will be administered for next three months. Seizure frequency, questionnaires evaluating mood and QOL, and adverse events are evaluated at each visit.
- Conditions
- Epilepsy
- Being tested
- Omega-3
- Keywords
- Medically intractable epilepsy, Omega-3
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Drug
Also called Omega-3, Omacor
1000mg every day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | One group of this study. Omega-3 will be administered for thee months. Receives: Drug: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Measured: three months
Secondary outcomes (4)
Depressive mood
BDI-2 questionnaire
Measured: three months
Anxiety
HAM-A questionnaire
Measured: three months
Quality of Life
SF-36 v2 questionnaire
Measured: three months
Adverse events
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
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 Seoul National 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kon Chu, Seoul National University Hospital
- Investigators
- Kon Chu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899741
- Sponsor's protocol ID
- 1508174702
- Status last verified
- Apr 2018
- First submitted
- 9 Sep 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT02899741
- Acronym / sponsor ID
- 1508174702
- Conditions
- Epilepsy
- Keywords
- Medically intractable epilepsy, Omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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.
The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.
Detailed description
This study will enroll total 30 patients with medically intractable epilepsy. The patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. After three months, Omega-3 will be administered for next three months. Seizure frequency, questionnaires evaluating mood and QOL, and adverse events are evaluated at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Drug: Omega-3One group of this study. Omega-3 will be administered for thee months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with medically intractable, focal or generalized, epilepsy: Patients with localization-related partial onset or generalized tonic/clonic seizure according to the International League Against Epilepsy (ILAE) can be included. Medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year.
- Seizure frequency criteria: three seizures per one month for recent 3 months before enrollment
- Seizure criteria: simple partial, complex partial, or tonic-clonic seizures
- Subjects with normal cognitive function: patients who can perform normal daily life. If not definite, enrollment will be done with K-MMSE score over 27.
Key exclusion criteria (10 listed)
- Poor general medical condition: comorbid with heart, lung, liver diseases
- Patients who have history of pseudo-seizure
- Anti-epileptic drugs has been changed in recent one month.
- Chronic alcoholic
- Seizure count cannot be done since seizures occur successively.
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 |
|---|---|---|
| Omega-3Also: Omega-3, Omacor1000mg every day for 90 days | Drug | Omega-3 |
Primary outcome
Seizure frequency
Time frame: three months
4 secondary outcomes
Depressive mood
Time frame: three months
Anxiety
Time frame: three months
Quality of Life
Time frame: three months
Adverse events
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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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.
Kon Chu, MD, PhD contact
Tae-Joon Kim, MD contact
Kon Chu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 in people with Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Apr 2018. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kon Chu, MD, PhD (stemcell.snu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: three months). 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 20 Apr 2018.