Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

NCT06716801 | Recruiting

• 1 other identifier: 169(A)MD23324
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Conditions

Focal Epilepsy With and Without Secondary Generalization

Keywords

focal-onset seizures; epilepsy

Outcome Measures

Primary Outcomes (1)

• Responder rate

  To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline.

  At 6 and at 12 months of maintenance treatment

Secondary Outcomes (6)

• Responder rate

  At 6 and at 12 months of maintenance-dosing treatment

• Safety evaluation

  0 -12 months of maintenance-dosing treatment

• Health-Related Quality of Life evaluation (QOLIE-31-P)

  At 6 and at 12 months maintenance-dosing treatment

• Health-Related Quality of Life evaluation (SF-6Dv2 )

  At 6 and at 12 months maintenance-dosing treatment

• Sleepiness status evaluation

  At 6 and at 12 months of maintenance-dosing treatment

Study Arms (1)

Patients affected by epilepsy with focal-onset seizures with or without secondary generalization

Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs).

Drug: Cenobamate

Interventions

Cenobamate DRUG

Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications.

Patients affected by epilepsy with focal-onset seizures with or without secondary generalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs).

You may qualify if:

• Male and female patients ≥18 years old at the time of cenobamate treatment initiation.
• Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization.
• Patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)/3 (for fourth line) concomitant anti-seizure medications (ASMs).
• Patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) ASMs before cenobamate treatment initiation (including concomitant ASMs started before initiating cenobamate).
• Patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation.
• Written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation.

You may not qualify if:

• Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).
• Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.
• Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.
• Patients with known substance abuse or dependence (except for caffeine and nicotine).
• Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit.
• Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit.
• Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

Hôpital TARNIER COCHIN

Paris, France, France

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

Cenobamate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Valeria Tellone

CONTACT

+393452493461; valeria.tellone@angelinipharma.com

Enrica Salvatori

CONTACT

+39 3458063168; Enrica.salvatori@angelinipharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 4, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2024-11

Locations

FR (1)