Phase 2
N=24
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00871377 ↗Enrolled (actual)
24
Serious AEs
1.6%
Results posted
Jan 2014
Primary outcome: Primary: Seizure Frequency — 0.655; 0.435; 0.631 Seizures per Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); High Dose Fish Oil (Drug); Low Dose Fish Oil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seizure Frequency |
0.655; 0.435; 0.631 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00871377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.