REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

Официальное название

Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study

Обзор

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.

Первичные конечные точки

• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines [Срок оценки: 0-12 months]

Вторичные конечные точки (10)

• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care [Срок оценки: 0-12 months]
• Effectiveness of cenobamate used as adjunctive therapy [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU) [Срок оценки: 0-12 months]
• Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions [Срок оценки: 0-12 months]
• Safety of cenobamate used as adjunctive therapy [Срок оценки: 0-12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 3 центра

• Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg — Freiburg im Breisgau
• Epileptologicum — Hamburg
• Diakonie Kork, Epilepsiezentrum — Kork

Испания · 3 центра

• 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

Великобритания · 2 центра

• Institute of Neurosciences NHS Greater Glasgow and Clyde — Glasgow
• Epilepsies - The Royal Wolverhampton NHS Trust — Wolverhampton

Нидерланды · 1 центр

• Kempenhaeghe - Academisch Centrum voor Epilepsie — Heeze

Швейцария · 1 центр

• Department of Neurology, University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT06922175 · 169(A)AV23432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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