Clinical trial NCT05867160: Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study
Official title: A 12-month, Prospective, Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
Focal-onset seizure
Cenobamate
Adjunctive Therapy
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Hippocrates Research
First posted: 2023-05-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with epilepsy having focal-onset seizures with or without secondary generalization not adequately controlled despite a history of treatment with at least 2 anti-seizure medications and who will meet all the inclusion and none of the exclusion study criteria.

The patients should be eligible to start a treatment with ASM as adjunctive therapy according to the physician's judgement, that must be clearly separated from the physician's decision to include the patient in the current study. The patients will be prospectively observed up to 12 months after having completed the related titration.

Brief summary: The purpose of this study is to describe the effectiveness of the adjunctive ASM treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.

Detailed description: The aim of the study is to assess the effectiveness and safety of adjunctive therapy in a real-world setting of patients affected by focal-onset seizures who are eligible to start the treatment with ASM as adjunctive therapy according to the physician's judgment.

Eligibility criteria: Inclusion Criteria:

* Male and female patients of any ethnic origin ≥18 years old at baseline.
* Patients with diagnosis of focal-onset seizures with or without secondary generalization.
* Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
* Patients should have clinical history of treatment failure with at least 2 ASMs.
* Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
* Written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ICH GCP guidelines

Exclusion Criteria:

* Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
* Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
* Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
* Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
* Patients with substance abuse or dependence (except for caffeine and nicotine).
* Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.

Primary outcomes:
measure: Change in seizure frequency at 6 months of maintenance
timeFrame: At 6 months of maintenance compared to baseline
Secondary outcomes:
measure: Change in seizure frequency at 3, 9, 12 months of maintenance
timeFrame: At 3, 9, 12 months of maintenance compared to baseline
measure: 50, 75, 90 Percent Responder rate
timeFrame: At 3, 6, 9, and 12 months of maintenance phase.
measure: 100 Percent Responder rate
timeFrame: At 3, 6, 9, and 12 months of maintenance phase.
measure: Retention rate
timeFrame: At 3, 6, 9, and 12 months of maintenance phase.
measure: Anxiety assessment
timeFrame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
measure: Depression assessment
timeFrame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
measure: Quality of life (QOL)
timeFrame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
measure: Cognitive assessment
timeFrame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
measure: Adverse events (AEs)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Study officials:
References: