Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study

N/AActive Not RecruitingNCT05867160

Aziende Chimiche Riunite Angelini Francesco S.p.A300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Epilepsy

Interventions

ASM as adjunctive therapyOTHER

ASM approved as adjunctive therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno

Milan, Italy

Outcomes

Primary Outcomes

Change in seizure frequency at 6 months of maintenance

The effectiveness of adjunctive ASM is measured as change in seizure frequency at 6 months of maintenance compared to baseline

Time frame: At 6 months of maintenance compared to baseline

Secondary Outcomes

Change in seizure frequency at 3, 9, 12 months of maintenance

The effectiveness of adjunctive ASM is measured as change in seizure frequency at 3, 9, 12 months of maintenance compared to baseline

Time frame: At 3, 9, 12 months of maintenance compared to baseline

50, 75, 90 Percent Responder rate

The effectiveness is measured as 50, 75, 90 Percent Responder rate

Time frame: At 3, 6, 9, and 12 months of maintenance phase.

100 Percent Responder rate

The effectiveness is measured as number/percentage of seizure free patients

Time frame: At 3, 6, 9, and 12 months of maintenance phase.

Retention rate

The effectiveness is measured as percentage of patients remaining in the study and on adjunctive therapy

Time frame: At 3, 6, 9, and 12 months of maintenance phase.

Anxiety assessment

The assessment is measured by means of the Generalized Anxiety Disorder (GAD-7) scale. Scoring GAD-7 Anxiety Severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.

Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.

Data from ClinicalTrials.gov

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