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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

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date February 27, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Seizure Frequency [ Time Frame: 18 months ]
number of seizures during the treatment period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01744275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HOPE-Epilepsy Trial
Official Title  ICMJE High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial
Brief Summary This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Dietary Supplement: Omega 3 fatty acids
  • Dietary Supplement: corn oil
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: corn oil
  • Experimental: Omega 3 fatty acids supplementation
    Omega 3 fatty acids capsules
    Intervention: Dietary Supplement: Omega 3 fatty acids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 5, 2012)
370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with active Epilepsy

Exclusion Criteria:

  • pregnant women or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744275
Other Study ID Numbers  ICMJE HCor
Research Institute - HCor ( Other Identifier: HCor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital do Coracao
Study Sponsor  ICMJE Hospital do Coracao
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital do Coracao
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP