HOPE-Epilepsy Trial

NCT ID: NCT01744275

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

corn oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Omega 3 fatty acids supplementation

Omega 3 fatty acids capsules

Group Type EXPERIMENTAL

Omega 3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega 3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

corn oil

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with active Epilepsy

Exclusion Criteria

* pregnant women or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M J Carrion, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

O Berwanger, PhD

Role: STUDY_CHAIR

Hospital do Coracao

R D Lopes, PhD

Role: STUDY_CHAIR

BCRI

F A Scorza, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Research Institute, Hospital do Coração

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Research Institute - HCor

Identifier Type: OTHER

Identifier Source: secondary_id

HCor

Identifier Type: -

Identifier Source: org_study_id

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