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

NCT00871377 | Completed Phase 2 Results DMC

• 1 other identifier: R21AT003420-01A2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

epilepsy; cardiac risk factors; memory; cognition; n-3 fatty acids; fish oil; EPA; DHA; seizures

Outcome Measures

Primary Outcomes (1)

• Seizure Frequency

  Seizure frequency (seizures per day or seizures per month)

  Study completion (42 weeks)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Corn Oil Placebo (n-6 fatty acids)

Drug: Placebo

High Dose Fish Oil

EXPERIMENTAL

2160 mg of EPA + DHA

Drug: High Dose Fish Oil

Low Dose Fish Oil

EXPERIMENTAL

1060 mg of EPA + DHA

Drug: Low Dose Fish Oil

Interventions

Placebo DRUG

corn oil (n-6 fatty acids)

Also known as: Corn Oil

Placebo

High Dose Fish Oil DRUG

n-3 fatty acids, 1060 mg EPA + DHA

High Dose Fish Oil

Low Dose Fish Oil DRUG

n-3 fatty acids, 2160 mg EPA + DHA

Low Dose Fish Oil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

UCLA General Clinical Research Center

Los Angeles, California, 90095, United States

Location

Related Publications (5)

• 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.

  PMID: 18721899 BACKGROUND

• 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. No abstract available.

  PMID: 18634902 BACKGROUND

• 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: 10.1016/j.yebeh.2010.06.011. Epub 2010 Jul 27.

  PMID: 20667792 RESULT

• Novak 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.

  PMID: 26696953 DERIVED

• DeGiorgio 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.

  PMID: 25201887 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Corn Oil; Fish Oils

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Christopher M. DeGiorgio, MD
• Organization: UCLA School of Medicine

cmd@mednet.ucla.edu

310-206-3753

Study Officials

• Christopher M DeGiorgio, MD

  David Geffen - UCLA School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 7, 2014
• Results First Posted: January 10, 2014

Record last verified: 2014-01

Locations

US (1)