HOPE-Epilepsy Trial (HOPE-Epilepsy)

February 25, 2014 updated by: Hospital do Coracao

High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial

This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04005-909
        • Research Institute, Hospital do Coração

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with active Epilepsy

Exclusion Criteria:

  • pregnant women or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: corn oil
Placebo
Experimental: Omega 3 fatty acids supplementation
Omega 3 fatty acids capsules
Dietary supplement: Omega 3 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency
Time Frame: 18 months
number of seizures during the treatment period
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 12 months
12 months
categorized seizure frequency
Time Frame: 18 months
number of crises categorized as: generalized, focal with disconnection and focal without disconnection
18 months
Percentage of overall seizure frequency modification
Time Frame: 18 months
percentage of reduction or increase in seizure frequency from baseline til the end of treatment period
18 months
Time Free of seizures during treatment
Time Frame: 12 months
12 months
Reduction in seizure frequency
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Investigators

  • Principal Investigator: M J Carrion, MD, Hospital do Coracao
  • Study Chair: O Berwanger, PhD, Hospital do Coracao
  • Study Chair: R D Lopes, PhD, BCRI
  • Study Chair: F A Scorza, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCor
  • Research Institute - HCor (Other Identifier: HCor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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