Back to resultsHOPE-Epilepsy Trial (HOPE-Epilepsy)
Primary Purpose
Epilepsy
Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Omega 3 fatty acids
corn oil
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Omega 3 fatty acids
Eligibility Criteria
Inclusion Criteria:
- Patients with active Epilepsy
Exclusion Criteria:
- pregnant women or breastfeeding
Sites / Locations
- Research Institute, Hospital do Coração
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Omega 3 fatty acids supplementation
Arm Description
Placebo
Omega 3 fatty acids capsules
Outcomes
Primary Outcome Measures
Seizure Frequency
number of seizures during the treatment period
Secondary Outcome Measures
categorized seizure frequency
number of crises categorized as: generalized, focal with disconnection and focal without disconnection
Percentage of overall seizure frequency modification
percentage of reduction or increase in seizure frequency from baseline til the end of treatment period
Time Free of seizures during treatment
Reduction in seizure frequency
Quality of Life
Full Information
NCT ID
NCT01744275
First Posted
December 4, 2012
Last Updated
February 25, 2014
Sponsor
Hospital do Coracao
1. Study Identification
Unique Protocol Identification Number
NCT01744275
Brief Title
HOPE-Epilepsy Trial
Acronym
HOPE-Epilepsy
Official Title
High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Suspended
Why Stopped
Lack of funding
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Omega 3 fatty acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Omega 3 fatty acids supplementation
Arm Type
Experimental
Arm Description
Omega 3 fatty acids capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 fatty acids
Intervention Type
Dietary Supplement
Intervention Name(s)
corn oil
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Seizure Frequency
Description
number of seizures during the treatment period
Time Frame
18 months
Secondary Outcome Measure Information:
Title
categorized seizure frequency
Description
number of crises categorized as: generalized, focal with disconnection and focal without disconnection
Time Frame
18 months
Title
Percentage of overall seizure frequency modification
Description
percentage of reduction or increase in seizure frequency from baseline til the end of treatment period
Time Frame
18 months
Title
Time Free of seizures during treatment
Time Frame
12 months
Title
Reduction in seizure frequency
Time Frame
12 months
Title
Quality of Life
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with active Epilepsy
Exclusion Criteria:
pregnant women or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M J Carrion, MD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
O Berwanger, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R D Lopes, PhD
Organizational Affiliation
BCRI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
F A Scorza, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Research Institute, Hospital do Coração
City
São Paulo
ZIP/Postal Code
04005-909
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
HOPE-Epilepsy Trial
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