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HOPE-Epilepsy Trial (HOPE-Epilepsy)

This study has suspended participant recruitment.
(Lack of funding)
Information provided by (Responsible Party):
Hospital do Coracao Identifier:
First received: December 4, 2012
Last updated: February 25, 2014
Last verified: February 2014
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .

Condition Intervention Phase
Epilepsy Dietary Supplement: Omega 3 fatty acids Dietary Supplement: corn oil Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial

Resource links provided by NLM:

Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Seizure Frequency [ Time Frame: 18 months ]
    number of seizures during the treatment period

Secondary Outcome Measures:
  • categorized seizure frequency [ Time Frame: 18 months ]
    number of crises categorized as: generalized, focal with disconnection and focal without disconnection

  • 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

  • Time Free of seizures during treatment [ Time Frame: 12 months ]
  • Reduction in seizure frequency [ Time Frame: 12 months ]
  • Quality of Life [ Time Frame: 12 months ]

Estimated Enrollment: 370
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Dietary Supplement: corn oil
Experimental: Omega 3 fatty acids supplementation
Omega 3 fatty acids capsules
Dietary Supplement: Omega 3 fatty acids


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with active Epilepsy

Exclusion Criteria:

  • pregnant women or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01744275

Research Institute, Hospital do Coração
São Paulo, Brazil, 04005-909
Sponsors and Collaborators
Hospital do Coracao
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
  More Information

Responsible Party: Hospital do Coracao Identifier: NCT01744275     History of Changes
Other Study ID Numbers: HCor
Research Institute - HCor ( Other Identifier: HCor )
Study First Received: December 4, 2012
Last Updated: February 25, 2014

Keywords provided by Hospital do Coracao:
Omega 3 fatty acids

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 21, 2017