EpilepsyPhase 2FOSNCT00871377
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
A Phase 2 study testing High Dose Fish Oil and Low Dose Fish Oil in people with Epilepsy, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- High Dose Fish Oil and Low Dose Fish Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 - 70
- History of intractable localization related/partial onset seizures and generalized tonic/clonic or tonic seizures defined according to International League Against Epilepsy (ILAE) classification as:
- A history compatible with localization related partial epilepsy
- A history of generalized tonic clonic or tonic seizures with loss of consciousness
- Three or more simple partial, complex partial or tonic-clonic seizures per month
- An EEG and/or an MRI consistent with a localization related epilepsy
- Evidence of at least three seizures per month for at least two months prior to the study
- Exposure to at least one antiepileptic drug at adequate dose
Who cannot join
- Significant or progressive medical, cardiac, or other illness
- Allergy to fish products or fish oil
- History of a coagulation disorder
- History of non-epileptic seizures
- Consumption of Fish Oil at any time 30 days or less prior to enrollment
- Any change in antiepileptic drugs for 30 days or less prior to enrollment
Show all 11Show fewer
- Treatment with Warfarin for 30 days or less prior to enrollment
- Previous poor compliance with therapy
- Drug or alcohol abuse
- Uncountable seizures as a result of seizure clustering, or inadequate supervision if the patient cannot count their own seizures.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA General Clinical Research Center
Los Angeles, California, 90095
About this study
Official title: Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures
The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.
Read the detailed description
Epilepsy is a common and disabling condition, characterized by recurrent seizures. Sudden unexpected death (SUDEP) is a major cause of mortality in people with epilepsy. SUDEP accounts for up to 20% of all cause mortality, and is most common in younger people, especially in their 20's to 40's year olds. In those with drug resistant epilepsy, SUDEP is five times more common than in well-controlled epilepsy. Likely causes of death include cardiac arrhythmias due to impaired autonomic regulation and reduced heart rate variability. Similarly, patients with recent myocardial infarction and congestive heart failure are at higher risk for sudden death, and manifest markedly reduced heart rate variability. Clinical studies of heart disease indicate that n-3 fatty acids, prevent cardiac arrhythmias, reduce mortality after myocardial infarction, and reduce the risk of sudden cardiac death. The mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of high frequency sodium and L-type calcium channels in the heart. In addition, n-3 fatty acids improve HRV in cardiac patients, and this reduction in HRV is postulated to be a marker of the anti-arrhythmic effect of n-3 fatty acids. Preliminary data from our group indicates that n-3 fatty acids improve HRV in people with epilepsy, especially those with low HRV (SDNN < 50). The commonality between n-3 fatty acids and improvement in HRV in patients with heart disease and epilepsy serves as a basis for our hypothesis that n-3 fatty acids may reduce the risk of SUDEP in epilepsy. The purpose of this proposal is to determine if n-3 fatty acids reduce seizures and modify cardiac risk in people with epilepsy who are at risk of SUDEP.
- Conditions
- Epilepsy
- Being tested
- Placebo, High Dose Fish Oil, Low Dose Fish Oil
- Keywords
- epilepsy, cardiac risk factors, memory, cognition, n-3 fatty acids, fish oil, EPA, DHA, seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Corn Oil
corn oil (n-6 fatty acids)
High Dose Fish OilDrug
n-3 fatty acids, 1060 mg EPA + DHA
Low Dose Fish OilDrug
n-3 fatty acids, 2160 mg EPA + DHA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Corn Oil Placebo (n-6 fatty acids) Receives: Drug: Placebo |
| High Dose Fish Oil | Experimental | 2160 mg of EPA + DHA Receives: Drug: High Dose Fish Oil |
| Low Dose Fish Oil | Experimental | 1060 mg of EPA + DHA Receives: Drug: Low Dose Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
Seizure frequency (seizures per day or seizures per month)
Measured: Study completion (42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, DeGiorgio, Chris, National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Christopher M DeGiorgio, MD, Principal investigator, David Geffen - UCLA School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871377
- Sponsor's protocol ID
- R21AT003420-01A2
- Acronym
- FOS
- Status last verified
- Jan 2014
- First submitted
- 27 Mar 2009
- Last updated
- 7 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
DeGiorgio CM, Miller P, Meymandi S, Gornbein JA. n-3 fatty acids (fish oil) for epilepsy, cardiac risk factors, and risk of SUDEP: clues from a pilot, double-blind, exploratory study. Epilepsy Behav. 2008 Nov;13(4):681-4. doi: 10.1016/j.yebeh.2008.08.001. Epub 2008 Sep 7.
PubMed 18721899DeGiorgio CM, Miller P. n-3 fatty acids (eicosapentanoic and docosahexanoic acids) in epilepsy and for the prevention of sudden unexpected death in epilepsy. Epilepsy Behav. 2008 Nov;13(4):712-3. doi: 10.1016/j.yebeh.2008.06.017. Epub 2008 Aug 9. No abstract available.
PubMed 18634902DeGiorgio CM, Miller P, Meymandi S, Chin A, Epps J, Gordon S, Gornbein J, Harper RM. RMSSD, a measure of vagus-mediated heart rate variability, is associated with risk factors for SUDEP: the SUDEP-7 Inventory. Epilepsy Behav. 2010 Sep;19(1):78-81. doi: 10.1016/j.yebeh.2010.06.011. Epub 2010 Jul 27.
PubMed 20667792Novak JL, Miller PR, Markovic D, Meymandi SK, DeGiorgio CM. Risk Assessment for Sudden Death in Epilepsy: The SUDEP-7 Inventory. Front Neurol. 2015 Dec 9;6:252. doi: 10.3389/fneur.2015.00252. eCollection 2015.
PubMed 26696953DeGiorgio CM, Miller PR, Harper R, Gornbein J, Schrader L, Soss J, Meymandi S. Fish oil (n-3 fatty acids) in drug resistant epilepsy: a randomised placebo-controlled crossover study. J Neurol Neurosurg Psychiatry. 2015 Jan;86(1):65-70. doi: 10.1136/jnnp-2014-307749. Epub 2014 Sep 8.
PubMed 25201887
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures
- ClinicalTrials.gov ID
- NCT00871377
- Acronym / sponsor ID
- FOS / R21AT003420-01A2
- Conditions
- Epilepsy
- Keywords
- epilepsy, cardiac risk factors, memory, cognition, n-3 fatty acids, fish oil, EPA, DHA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 10 Jan 2014
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 if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.
Detailed description
Epilepsy is a common and disabling condition, characterized by recurrent seizures. Sudden unexpected death (SUDEP) is a major cause of mortality in people with epilepsy. SUDEP accounts for up to 20% of all cause mortality, and is most common in younger people, especially in their 20's to 40's year olds. In those with drug resistant epilepsy, SUDEP is five times more common than in well-controlled epilepsy. Likely causes of death include cardiac arrhythmias due to impaired autonomic regulation and reduced heart rate variability. Similarly, patients with recent myocardial infarction and congestive heart failure are at higher risk for sudden death, and manifest markedly reduced heart rate variability. Clinical studies of heart disease indicate that n-3 fatty acids, prevent cardiac arrhythmias, reduce mortality after myocardial infarction, and reduce the risk of sudden cardiac death. The mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of high frequency sodium and L-type calcium channels in the heart. In addition, n-3 fatty acids improve HRV in cardiac patients, and this reduction in HRV is postulated to be a marker of the anti-arrhythmic effect of n-3 fatty acids. Preliminary data from our group indicates that n-3 fatty acids improve HRV in people with epilepsy, especially those with low HRV (SDNN < 50). The commonality between n-3 fatty acids and improvement in HRV in patients with heart disease and epilepsy serves as a basis for our hypothesis that n-3 fatty acids may reduce the risk of SUDEP in epilepsy. The purpose of this proposal is to determine if n-3 fatty acids reduce seizures and modify cardiac risk in people with epilepsy who are at risk of SUDEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboCorn Oil Placebo (n-6 fatty acids) |
| High Dose Fish Oil | Experimental | Drug: High Dose Fish Oil2160 mg of EPA + DHA |
| Low Dose Fish Oil | Experimental | Drug: Low Dose Fish Oil1060 mg of EPA + DHA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, age 18 - 70
- History of intractable localization related/partial onset seizures and generalized tonic/clonic or tonic seizures defined according to International League Against Epilepsy (ILAE) classification as:
- A history compatible with localization related partial epilepsy
- A history of generalized tonic clonic or tonic seizures with loss of consciousness
- Three or more simple partial, complex partial or tonic-clonic seizures per month
Key exclusion criteria (11 listed)
- Significant or progressive medical, cardiac, or other illness
- Allergy to fish products or fish oil
- History of a coagulation disorder
- History of non-epileptic seizures
- Consumption of Fish Oil at any time 30 days or less prior to enrollment
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 |
|---|---|---|
| PlaceboAlso: Corn Oilcorn oil (n-6 fatty acids) | Drug | Placebo |
| High Dose Fish Oiln-3 fatty acids, 1060 mg EPA + DHA | Drug | High Dose Fish Oil |
| Low Dose Fish Oiln-3 fatty acids, 2160 mg EPA + DHA | Drug | Low Dose Fish Oil |
Primary outcome
Seizure Frequency
Time frame: Study completion (42 weeks)
Seizure frequency (seizures per day or seizures per month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18721899DeGiorgio CM, Miller P, Meymandi S, Gornbein JA. n-3 fatty acids (fish oil) for epilepsy, cardiac risk factors, and risk of SUDEP: clues from a pilot, double-blind, exploratory study. Epilepsy Behav. 2008 Nov;13(4):681-4. doi: 10.1016/j.yebeh.2008.08.001. Epub 2008 Sep 7.
- Background: PubMed 18634902DeGiorgio CM, Miller P. n-3 fatty acids (eicosapentanoic and docosahexanoic acids) in epilepsy and for the prevention of sudden unexpected death in epilepsy. Epilepsy Behav. 2008 Nov;13(4):712-3. doi: 10.1016/j.yebeh.2008.06.017. Epub 2008 Aug 9. No abstract available.
- Results publication: PubMed 20667792DeGiorgio CM, Miller P, Meymandi S, Chin A, Epps J, Gordon S, Gornbein J, Harper RM. RMSSD, a measure of vagus-mediated heart rate variability, is associated with risk factors for SUDEP: the SUDEP-7 Inventory. Epilepsy Behav. 2010 Sep;19(1):78-81. doi: 10.1016/j.yebeh.2010.06.011. Epub 2010 Jul 27.
- Derived from this study: PubMed 26696953Novak JL, Miller PR, Markovic D, Meymandi SK, DeGiorgio CM. Risk Assessment for Sudden Death in Epilepsy: The SUDEP-7 Inventory. Front Neurol. 2015 Dec 9;6:252. doi: 10.3389/fneur.2015.00252. eCollection 2015.
- Derived from this study: PubMed 25201887DeGiorgio CM, Miller PR, Harper R, Gornbein J, Schrader L, Soss J, Meymandi S. Fish oil (n-3 fatty acids) in drug resistant epilepsy: a randomised placebo-controlled crossover study. J Neurol Neurosurg Psychiatry. 2015 Jan;86(1):65-70. doi: 10.1136/jnnp-2014-307749. Epub 2014 Sep 8.
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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.
Christopher M DeGiorgio, MD principal investigator
David Geffen - UCLA School of Medicine
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 High Dose Fish Oil and Low Dose Fish Oil in people with Epilepsy, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 8 inclusion and 11 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 7 Feb 2014. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Seizure Frequency (time frame: Study completion (42 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871377, which also lists 5 linked publications.
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 7 Feb 2014.