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
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 April 23, 2014