EpilepsyPhase 2/3HOPE-EpilepsyNCT01744275
HOPE-Epilepsy Trial
A Phase 2/3 study testing Omega 3 fatty acids and corn oil in people with Epilepsy, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Omega 3 fatty acids and corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with active Epilepsy
Who cannot join
- pregnant women or breastfeeding
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Research Institute, Hospital do Coração
São Paulo, São Paulo, 04005-909
About this study
Official title: High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .
- Conditions
- Epilepsy
- Being tested
- Omega 3 fatty acids, corn oil
- Keywords
- Epilepsy, Omega 3 fatty acids
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidsDietary supplement
corn oilDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: corn oil |
| Omega 3 fatty acids supplementation | Experimental | Omega 3 fatty acids capsules Receives: Dietary Supplement: Omega 3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
number of seizures during the treatment period
Measured: 18 months
Secondary outcomes (5)
categorized seizure frequency
number of crises categorized as: generalized, focal with disconnection and focal without disconnection
Measured: 18 months
Percentage of overall seizure frequency modification
percentage of reduction or increase in seizure frequency from baseline til the end of treatment period
Measured: 18 months
Time Free of seizures during treatment
Measured: 12 months
Reduction in seizure frequency
Measured: 12 months
Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M J Carrion, MD, Principal investigator, Hospital do CoracaoO Berwanger, PhD, Study chair, Hospital do CoracaoR D Lopes, PhD, Study chair, BCRIF A Scorza, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744275
- Sponsor's protocol ID
- HCor
- Other IDs
- Research Institute - HCor
- Acronym
- HOPE-Epilepsy
- Status last verified
- Feb 2014
- First submitted
- 4 Dec 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Omega 3 Fatty Acids Supplementation in Patients With Epilepsy : The HOPE-Epilepsy Trial
- ClinicalTrials.gov ID
- NCT01744275
- Acronym / sponsor ID
- HOPE-Epilepsy / HCor
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Omega 3 fatty acids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of funding
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: corn oilPlacebo |
| Omega 3 fatty acids supplementation | Experimental | Dietary Supplement: Omega 3 fatty acidsOmega 3 fatty acids capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with active Epilepsy
Key exclusion criteria (1 listed)
- pregnant women or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acids | Dietary supplement | Omega 3 fatty acids supplementation |
| corn oilPlacebo | Dietary supplement | Placebo |
Primary outcome
Seizure Frequency
Time frame: 18 months
number of seizures during the treatment period
5 secondary outcomes
categorized seizure frequency
Time frame: 18 months
Percentage of overall seizure frequency modification
Time frame: 18 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M J Carrion, MD principal investigator
Hospital do Coracao
O Berwanger, PhD study chair
Hospital do Coracao
R D Lopes, PhD study chair
BCRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega 3 fatty acids and corn oil in people with Epilepsy, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Frequency (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.