Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures

Epilepsy Clinical Trial

— FOS  

Official title:

Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871377
• Other study ID #: R21AT003420-01A2
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2009
• Last updated: January 9, 2014
• Start date: May 2008
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Placebo
corn oil (n-6 fatty acids)
• High Dose Fish Oil
n-3 fatty acids, 1060 mg EPA + DHA
• Low Dose Fish Oil
n-3 fatty acids, 2160 mg EPA + DHA

Locations

Country	Name	City	State
United States	UCLA General Clinical Research Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

DeGiorgio 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 — View Citation

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. — View Citation

DeGiorgio 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Frequency	Seizure frequency (seizures per day or seizures per month)	Study completion (42 weeks)	No