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HOPE-Epilepsy Trial (HOPE-Epilepsy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744275
Recruitment Status : Suspended (Lack of funding)
First Posted : December 6, 2012
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

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

Condition or disease Intervention/treatment Phase
Epilepsy Dietary Supplement: Omega 3 fatty acids Dietary Supplement: corn oil Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
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
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Arm Intervention/treatment
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


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


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

  2. 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

  3. Time Free of seizures during treatment [ Time Frame: 12 months ]
  4. Reduction in seizure frequency [ Time Frame: 12 months ]
  5. Quality of Life [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with active Epilepsy

Exclusion Criteria:

  • pregnant women or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744275


Locations
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Brazil
Research Institute, Hospital do Coração
São Paulo, Brazil, 04005-909
Sponsors and Collaborators
Hospital do Coracao
Investigators
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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
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01744275    
Other Study ID Numbers: HCor
Research Institute - HCor ( Other Identifier: HCor )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014
Keywords provided by Hospital do Coracao:
Epilepsy
Omega 3 fatty acids
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases