EpilepsyNCT02573272
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
An observational study of Epilepsy, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial summary
Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- eslicarbacepine
- How many people
- 204 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Oct 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with focal epilepsy on stable treatment for the last two years
Who may be able to join
- Patients over 18 years
- patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests.
- patients with stable and identifiable antiepileptic treatment during the last two years.
- patients according to the investigator are able to provide clinical data necessary for the development of the study
- Patients who signed informed consent
Who cannot join
- Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Torrecardenas
Almería, Almeria, 04009
Pedro Serrano
About this study
Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.
- Conditions
- Epilepsy
- Being tested
- eslicarbacepine
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eslicarbacepineDrug
| Study group | Role | What they receive |
|---|---|---|
| Epileptic patients with AEDs and eslicarbacepine | Not described Receives: Drug: eslicarbacepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid IMT millimeters
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
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
- Observational
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573272
- Sponsor's protocol ID
- FPS-ESL-2105-01
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02573272
- Acronym / sponsor ID
- FPS-ESL-2105-01
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Oct 2015 (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.
Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic patients with AEDs and eslicarbacepine | – | Drug: eslicarbacepine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with focal epilepsy on stable treatment for the last two years
Key inclusion criteria (5 listed)
- Patients over 18 years
- patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests.
- patients with stable and identifiable antiepileptic treatment during the last two years.
- patients according to the investigator are able to provide clinical data necessary for the development of the study
- Patients who signed informed consent
Key exclusion criteria (1 listed)
- Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.
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 |
|---|---|---|
| eslicarbacepine | Drug | Epileptic patients with AEDs and eslicarbacepine |
Primary outcome
Carotid IMT millimeters
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Oct 2015. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact María del Mar Benjumea (955 040 460, maria.benjumea@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid IMT millimeters (time frame: one year). 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 9 Oct 2015.