Trials / Unknown
UnknownNCT04221282
ZEBinix® Retention Rate in Epilepsy in Elderly Patients
ZEBinix Retention Rate in Epilepsy in Elderly Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zebinix | 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. |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2020-09-30
- Completion
- 2020-09-30
- First posted
- 2020-01-09
- Last updated
- 2020-01-09
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04221282. Inclusion in this directory is not an endorsement.