REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
NCT ID: NCT06922175
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-12-19
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Adult patients affected by epilepsy with focal-onset seizures
Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more ASMs (anti-seizure medications), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and HCRU (if any) prior to cenobamate starting date.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date;
4. Patients with at least 6 months of data coverage in the medical records prior to the index date;
5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
6. 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
2. Patients who started cenobamate within an EAP;
3. Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
4. Patients with specific syndrome (e.g. LGS and Dravet);
5. Pregnancy or lactation;
6. Patients without self-judgement ability;
7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.
18 Years
ALL
No
Sponsors
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1Med
OTHER
Aziende Chimiche Riunite Angelini Francesco S.p.A
INDUSTRY
Responsible Party
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Locations
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Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, Germany
Epileptologicum
Hamburg, Germany, Germany
Diakonie Kork, Epilepsiezentrum
Kork, Germany, Germany
Kempenhaeghe - Academisch Centrum voor Epilepsie
Heeze, Netherlands, Netherlands
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Barcelona, Spain, Spain
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Madrid, Spain, Spain
Consorcio Hosp. General Universitario Valencia
Valencia, Spain, Spain
Department of Neurology, University Hospital Zurich
Zurich, Switzerland, Switzerland
Institute of Neurosciences NHS Greater Glasgow and Clyde
Glasgow, UK, United Kingdom
Epilepsies - The Royal Wolverhampton NHS Trust
Wolverhampton, UK, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Andreas Schulze-Bonhage
Role: primary
Patrick House
Role: primary
Bernhard Steinhoff
Role: primary
H.J.M. Marian Majoie
Role: primary
Manuel Toledo Argany
Role: primary
Irene Garcia Morales
Role: primary
Ascensión Castillo Ruiz
Role: primary
Marian Galovic
Role: primary
Craig Heath
Role: primary
Phil Tittensor
Role: primary
Other Identifiers
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169(A)AV23432
Identifier Type: -
Identifier Source: org_study_id
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