HOPE-Epilepsy Trial

Phase 2

Suspended

• Conditions: Epilepsy
• Interventions: Dietary Supplement: corn oil; Dietary Supplement: Omega 3 fatty acids

• Registration Number: NCT01744275
• Lead Sponsor: Hospital do Coracao

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-25
• Last Update Posted: 2014-02-27
• Primary Completion: 2014-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Patients with active Epilepsy

Exclusion Criteria

• pregnant women or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	corn oil	Placebo
Omega 3 fatty acids supplementation	Omega 3 fatty acids	Omega 3 fatty acids capsules

Primary Outcome Measures

Name	Time	Method
Seizure Frequency	18 months	number of seizures during the treatment period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Institute, Hospital do Coração; 🇧🇷 São Paulo, Brazil