EpilepsyZEBRENCT04221282
ZEBinix® Retention Rate in Epilepsy in Elderly Patients
An observational study of Epilepsy and Aging Disorder, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Epilepsy, Aging Disorder, Aging
- What is being tested?
- Zebinix
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Sep 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients ≥ 65 years that undergo at least one seizure in the last three months and with no history of ESL tratment or history of epilepsy status will be screened. ESL will be initiated by the investigator in patients with refractory partial seizures with or without generalized seizures or with PGTC seizures as a first line monotherapy or adjunctive therapy. In case of inefficacy or toxicity the dose of ESL will be gradually titrated up to 1 600 mg or titrated down to 600 mg, respectively.
Who may be able to join
- Age ≥ 65 years
- Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion)
- Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures
- At least one seizure in the last three months
- Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy
Who cannot join
- History of ESL treatment
- History of status epilepticus, seizures occurring in cluster, pseudo-seizures
- History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 times ULN, gamma-glutamyltranspeptidase (GGT) > 5 times ULN)
- History of severe renal impairment (clearance CLCR <30ml/min)
- History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine)
- History of severe hyponatremia (< 120 mmol/L)
- Second or third degree atrioventricular block
- More than one other antiepileptic drug
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier St Joseph St Luc
Lyon, 69007
Adrien DIDELOT, MD, PhD, 0033478616172
About this study
Official title: ZEBinix Retention Rate in Epilepsy in Elderly Patients
The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. ESL is approved in Europe and the USA as adjunctive or monotherapy in adults with partial-onset seizures. Nevertheless, retrospective data in monotherapy condition in the elderly epileptic population are sparse. The aim of the ZEBRE study is to evaluate the efficacy and the safety of ESL in elderly epileptic patients (> 65 years). The completion of this study will provide crucial information on the most appropriate ESL treatment for elderly patients suffering from partial seizures.
Read the detailed description
The ZEBRE (ZEBinix® Retention rate in epilepsy in Elderly patients) study is a prospective, multicenter, descriptive study. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics.
- Conditions
- Epilepsy, Aging Disorder, Aging, Epilepsy; Seizure
- Being tested
- Zebinix
- Keywords
- epilepsy, elderly, aging, zebinix, Eslicarbazepine acetate, tolerance, antiepileptic drug
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZebinixDrug
Also called Eslicarbazepine acetate (ESL)
ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Epileptic elderly patients | Elderly patients with partial-onset seizures Receives: Drug: Zebinix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.
The retention rate is representative of the effect of ESL since ESL will be pursued only if ESL has a sufficient efficacy without adverse effect. To evaluate the effect of ESL in elderly patients with partial-onset seizures, the retention rate will be measured after 6 months of treatment with ESL.
Measured: at the end of the study treatment, at 6 months
Secondary outcomes (6)
Quality of life of patients as assessed by QOLIE-10 questionnaire
QOLIE-10 (quality of life in epilepsy) is a quality of life questionnaire for adults with epilepsy. There are 10 questions about health and daily activities. All positive responses are lower numbers and all negative responses are higher numbers.
Measured: at each visits required by the study (baseline, 3 months and 6 months)
Quality of life of patients as assessed by QoL-AD questionnaire
Some patients with epilepsy also have cognitive decline. QOL-AD (quality of life in Alzheimer'disease) measure quality of life in people with severe cognitive decline. A total score of 13-52, with higher scores indicating better QoL.
Measured: at each visits required by the study (baseline, 3 months and 6 months)
Quality of life of patients as assessed by NDDIE questionnaire
NDDI-E (neurological disorder depression inventory for epilepsy) is used for detecting major depressive disorder; a total score above 15 should raise the suspicion of a major depressive episode.
Measured: at each visits required by the study (baseline, 3 months and 6 months)
Incidence of treatment- adverse events as assessed by adverse events reports
Number of patients with treatment-related adverse events will be reported to the pharmacovigilance department. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment will be assessed.
Measured: through study completion, an average of 6 months
Incidence of seizures as assessed by the occurrence of seizures
The number and the type of seizures or the number of seizure free in elderly patients will be reported
Measured: at each visits required by the study (baseline, 3 months and 6 months)
Observance of the treatment as recorded by the control of the drug administration
The treatment delivery by the pharmacy be performed to assess the compliance of the treatment.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Apr 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien DIDELOT, MD, PhD, Principal investigator, Centre Hospitalier saint Joseph St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221282
- Sponsor's protocol ID
- ZEBRE
- Acronym
- ZEBRE
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZEBinix Retention Rate in Epilepsy in Elderly Patients
- ClinicalTrials.gov ID
- NCT04221282
- Acronym / sponsor ID
- ZEBRE / ZEBRE
- Conditions
- Epilepsy, Aging Disorder, Aging, Epilepsy; Seizure
- Keywords
- epilepsy, elderly, aging, zebinix, Eslicarbazepine acetate, tolerance, antiepileptic drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 9 Jan 2020 (actual)
- 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.
The incidence of provoked and unprovoked seizures is known to increase with advancing age. Eslicarbazepine acetate (ESL) is one of the third generation of antiepileptic drugs (AEDs) that have been developed in the last ten years with a favorable safety profile. ESL is approved in Europe and the USA as adjunctive or monotherapy in adults with partial-onset seizures. Nevertheless, retrospective data in monotherapy condition in the elderly epileptic population are sparse. The aim of the ZEBRE study is to evaluate the efficacy and the safety of ESL in elderly epileptic patients (> 65 years). The completion of this study will provide crucial information on the most appropriate ESL treatment for elderly patients suffering from partial seizures.
Detailed description
The ZEBRE (ZEBinix® Retention rate in epilepsy in Elderly patients) study is a prospective, multicenter, descriptive study. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptic elderly patients | – | Drug: ZebinixElderly patients with partial-onset seizures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients ≥ 65 years that undergo at least one seizure in the last three months and with no history of ESL tratment or history of epilepsy status will be screened. ESL will be initiated by the investigator in patients with refractory partial seizures with or without generalized seizures or with PGTC seizures as a first line monotherapy or adjunctive therapy. In case of inefficacy or toxicity the dose of ESL will be gradually titrated up to 1 600 mg or titrated down to 600 mg, respectively.
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion)
- Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures
- At least one seizure in the last three months
- Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy
Key exclusion criteria (8 listed)
- History of ESL treatment
- History of status epilepticus, seizures occurring in cluster, pseudo-seizures
- History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 times ULN, gamma-glutamyltranspeptidase (GGT) > 5 times ULN)
- History of severe renal impairment (clearance CLCR <30ml/min)
- History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine)
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 |
|---|---|---|
| ZebinixAlso: Eslicarbazepine acetate (ESL)ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected. | Drug | Epileptic elderly patients |
Primary outcome
Retention rate of ESL treatment as assessed by the number of patients that are still included in the study.
Time frame: at the end of the study treatment, at 6 months
The retention rate is representative of the effect of ESL since ESL will be pursued only if ESL has a sufficient efficacy without adverse effect. To evaluate the effect of ESL in elderly patients with partial-onset seizures, the retention rate will be measured after 6 months of treatment with ESL.
6 secondary outcomes
Quality of life of patients as assessed by QOLIE-10 questionnaire
Time frame: at each visits required by the study (baseline, 3 months and 6 months)
Quality of life of patients as assessed by QoL-AD questionnaire
Time frame: at each visits required by the study (baseline, 3 months and 6 months)
Quality of life of patients as assessed by NDDIE questionnaire
Time frame: at each visits required by the study (baseline, 3 months and 6 months)
Incidence of treatment- adverse events as assessed by adverse events reports
Time frame: through study completion, an average of 6 months
Incidence of seizures as assessed by the occurrence of seizures
Time frame: at each visits required by the study (baseline, 3 months and 6 months)
Observance of the treatment as recorded by the control of the drug administration
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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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.
Adrien DIDELOT, MD, PhD principal investigator
Centre Hospitalier saint Joseph St Luc
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 and Aging Disorder, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
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 8 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 Jan 2020. 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 France. 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 Adrien DIDELOT, MD, PhD (0033478616172, adidelot@ch-stjoseph-stluc-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate of ESL treatment as assessed by the number of patients that are still included in the study. (time frame: at the end of the study treatment, at 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 9 Jan 2020.