HOPE-Epilepsy Trial

Epilepsy Clinical Trial

— HOPE-Epilepsy  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01744275
• Other study ID #: HCor
• Secondary ID: Research Institu
• Status: Suspended
• Phase: Phase 2/Phase 3
• First received: December 4, 2012
• Last updated: February 25, 2014
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2014
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Comittee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 370
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with active Epilepsy

Exclusion Criteria:

• pregnant women or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Dietary Supplement:
• Omega 3 fatty acids

• corn oil
Placebo

Locations

Country	Name	City	State
Brazil	Research Institute, Hospital do Coração	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure Frequency	number of seizures during the treatment period	18 months	No
Secondary	categorized seizure frequency	number of crises categorized as: generalized, focal with disconnection and focal without disconnection	18 months	No
Secondary	Percentage of overall seizure frequency modification	percentage of reduction or increase in seizure frequency from baseline til the end of treatment period	18 months	No
Secondary	Time Free of seizures during treatment		12 months	No
Secondary	Reduction in seizure frequency		12 months	No
Secondary	Quality of Life		12 months	No