HOPE-Epilepsy Trial (HOPE-Epilepsy)
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ClinicalTrials.gov Identifier: NCT01744275 |
Recruitment Status :
Suspended
(Lack of funding)
First Posted : December 6, 2012
Last Update Posted : February 27, 2014
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Sponsor:
Hospital do Coracao
Information provided by (Responsible Party):
Hospital do Coracao
Tracking Information | |||||||||||||
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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 |
Seizure Frequency [ Time Frame: 18 months ] number of seizures during the treatment period
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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 |
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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 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Epilepsy | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Suspended | ||||||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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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 |