Recruiting NCT06922175
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Epilepsy With Uncontrolled Focal-onset Seizures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Netherlands, Spain, Switzerland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study
Overview
The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.
Primary outcome measures
- Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines [Time frame: 0-12 months]
Secondary outcome measures (10)
- Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care [Time frame: 0-12 months]
- Effectiveness of cenobamate used as adjunctive therapy [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU) [Time frame: 0-12 months]
- Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions [Time frame: 0-12 months]
- Safety of cenobamate used as adjunctive therapy [Time frame: 0-12 months]
Eligibility criteria
Inclusion criteria
- Male and female patients of any ethnic origin ≥18 years old at index date;
- Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date;
- Patients presenting at least 1 seizure a month in the last 6 months prior to index date;
- Patients with at least 6 months of data coverage in the medical records prior to the index date;
- Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
- Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation.
Exclusion criteria
- Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;
- Patients who started cenobamate within an EAP;
- Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
- Patients with specific syndrome (e.g. LGS and Dravet);
- Pregnancy or lactation;
- Patients without self-judgement ability;
- Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
- Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg — Freiburg im Breisgau
- Epileptologicum — Hamburg
- Diakonie Kork, Epilepsiezentrum — Kork
Spain · 3 centers
- Epilepsy Unit - Neurology Department Valle de Hebron Hospital — Barcelona
- Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos — Madrid
- Consorcio Hosp. General Universitario Valencia — Valencia
United Kingdom · 2 centers
- Institute of Neurosciences NHS Greater Glasgow and Clyde — Glasgow
- Epilepsies - The Royal Wolverhampton NHS Trust — Wolverhampton
Netherlands · 1 center
- Kempenhaeghe - Academisch Centrum voor Epilepsie — Heeze
Switzerland · 1 center
- Department of Neurology, University Hospital Zurich — Zurich
Identifiers
NCT: NCT06922175 · 169(A)AV23432