HOPE-Epilepsy Trial

This study has suspended participant recruitment.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01744275
First received: December 4, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    number of seizures during the treatment period


Secondary Outcome Measures:
  • categorized seizure frequency [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    number of crises categorized as: generalized, focal with disconnection and focal without disconnection

  • Percentage of overall seizure frequency modification [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Reduction in seizure frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
Placebo
Dietary Supplement: corn oil
Placebo
Experimental: Omega 3 fatty acids supplementation
Omega 3 fatty acids capsules
Dietary Supplement: Omega 3 fatty acids

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01744275

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

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01744275     History of Changes
Other Study ID Numbers: HCor, Research Institute - HCor
Study First Received: December 4, 2012
Last Updated: February 25, 2014
Health Authority: Brazil: Ethics Comittee

Keywords provided by Hospital do Coracao:
Epilepsy
Omega 3 fatty acids

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014