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HOPE-Epilepsy Trial

High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial

Status
Suspended
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01744275
Acronym
HOPE-Epilepsy
Enrollment
370
Registered
2012-12-06
Start date
2013-07-31
Completion date
2016-07-31
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Omega 3 fatty acids

Brief summary

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

Interventions

DIETARY_SUPPLEMENTOmega 3 fatty acids
DIETARY_SUPPLEMENTcorn oil

Placebo

Sponsors

Hospital do Coracao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with active Epilepsy

Exclusion criteria

* pregnant women or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Seizure Frequency18 monthsnumber of seizures during the treatment period

Secondary

MeasureTime frameDescription
categorized seizure frequency18 monthsnumber of crises categorized as: generalized, focal with disconnection and focal without disconnection
Percentage of overall seizure frequency modification18 monthspercentage of reduction or increase in seizure frequency from baseline til the end of treatment period
Time Free of seizures during treatment12 months
Reduction in seizure frequency12 months
Quality of Life12 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026