Partial Onset SeizuresNCT01830400
A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)
An observational study of Partial Onset Seizures, run by Eisai Inc. at 106 sites in 8 countries.
Trial summary
This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- Eslicarbazepine Acetate tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 254 participants
- Where
- 106 sitesin 8 countries
- Study dates
- Apr 2012to Jun 2014
- 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: Normal clinical practice setting/ centre.
Who may be able to join
- The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
- Patients treated with one drug licensed for monotherapy in partial onset seizures
- Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL
- Patient was prescribed ESL no longer than 2 weeks before the baseline
- Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
- Aged 18 years or older
- Signed written informed consent
Who cannot join
- Patients that had started ESL outside the approved SPC at enrolment
- Simultaneous participation in an interventional clinical trial
Trial locations and contacts
106 sites in 8 countries.
106 sites in 8 countries
Germany57 sites
Study site
Altenholz
Study site
Asperg
Study site
Augsburg
Study site
Bad Berka
Study site
Bad Langensalza
Study site
Berlin
Study site
Beuel
Study site
Bielefeld
Study site
Bochum
Study site
Bockhorn
Study site
Buxtehude
Study site
Cologne
Study site
Dortmund
Study site
Erbach im Odenwald
Study site
Erlangen
Study site
Etville
Study site
Gelsenkirchen
Study site
Gera
Study site
Greiz
Study site
Grevenbroich
Study site
Guelders
Study site
Hamburg
Study site
Hamm
Study site
Heilbad Heiligenstadt
Study site
Herdecke
Study site
Hildesheim
Study site
Hof
Study site
Ilmenau
Study site
Itzehoe
Study site
Kamp-Lintfort
Study site
Kirchen (Sieg)
Study site
Königsbrück
Study site
Leipzig
Study site
Leverkusen
Study site
Lohr a. Main
Study site
Ludwigsburg
Study site
Mannheim
Study site
Mittweida
Study site
München
Study site
Oranienburg
Study site
Osnabrück
Study site
Quakenbrück
Study site
Rathenow
Study site
Salzgitter
Study site
Schirgiswalde-Kirschau
Study site
Schorndorf
Study site
Schwäbisch Gmünd
Study site
Senftenberg
Study site
Solingen
Study site
Stuttgart
Study site
Troisdorf (Sieglar)
Study site
Waiblingen
Study site
Wesel
Study site
Westerstede
Study site
Wilhelmshaven
Study site
Wolfsburg
Study site
Würzburg
France14 sites
Study site
Altkirch
Study site
Armentières
Study site
Bergerac
Study site
Biarritz
Study site
Chaumont
Study site
Cholet
Study site
Gap
Study site
Nice
Study site
Nîmes
Study site
Paris
Study site
Perpignan
Study site
Rueil-Malmaison
Study site
Sarreguemines
Study site
Toulon
United Kingdom11 sites
Study site
Birmingham
Study site
Dundee
Study site
London
Study site
Middlesbrough
Study site
Newport
Study site
Romford
Study site
Salford
Study site
Stoke-on-Trent
Study site
Telford
Study site
Torquay, Devon
Study site
Truro
Denmark10 sites
Study site
Aalborg
Study site
Arhus C
Study site
Copenhagen
Study site
Dianalund
Study site
Esbjerg
Study site
Glostrup Municipality
Study site
Holstebro
Study site
Roskilde
Study site
Sønderborg
Study site
Vejle
Sweden5 sites
Study site
Angered
Study site
Helsingborg
Study site
Kungsbacka
Study site
Linköping
Study site
Stockholm / Saint Goran
About this study
Official title: An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation
This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.
- Conditions
- Partial Onset Seizures
- Being tested
- Eslicarbazepine Acetate tablets
- Keywords
- ESL, Partial onset seizures, Retention Rate, Seizure Control, Antiepileptic, Secondary Generalisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine Acetate tabletsDrug
Also called ESL
The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine Acetate tablets | Not described Receives: Drug: Eslicarbazepine Acetate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline
Measured: 6 months
Secondary outcomes (1)
Change in Overall Seizure Frequency after 3 and 6 months from Baseline
Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ESL.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset SeizuresStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Holtkamp, Dr., Principal investigator, Klinische und Experimentelle Epileptologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830400
- Sponsor's protocol ID
- E2093-E044-404
- Status last verified
- Aug 2015
- First submitted
- 8 Apr 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation
- ClinicalTrials.gov ID
- NCT01830400
- Acronym / sponsor ID
- E2093-E044-404
- Conditions
- Partial Onset Seizures
- Keywords
- ESL, Partial onset seizures, Retention Rate, Seizure Control, Antiepileptic, Secondary Generalisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Apr 2013 (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 was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine Acetate tablets | – | Drug: Eslicarbazepine Acetate tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Normal clinical practice setting/ centre.
Key inclusion criteria (7 listed)
- The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
- Patients treated with one drug licensed for monotherapy in partial onset seizures
- Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL
- Patient was prescribed ESL no longer than 2 weeks before the baseline
- Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
Key exclusion criteria (2 listed)
- Patients that had started ESL outside the approved SPC at enrolment
- Simultaneous participation in an interventional clinical trial
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 |
|---|---|---|
| Eslicarbazepine Acetate tabletsAlso: ESLThe Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study. | Drug | Eslicarbazepine Acetate tablets |
Primary outcome
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline
Time frame: 6 months
1 secondary outcome
Change in Overall Seizure Frequency after 3 and 6 months from Baseline
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Related trials for Partial Onset Seizures
Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
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Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
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.
Martin Holtkamp, Dr. principal investigator
Klinische und Experimentelle Epileptologie
106 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Onset Seizures, run by Eisai Inc. at 106 sites in 8 countries.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in Germany, France, United Kingdom, Denmark, Sweden and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline (time frame: 6 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 19 Aug 2015.