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

NCT ID: NCT05867160

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-09-30

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients with focal-onset seizures starting a treatment with ASM as adjunctive therapy

Adult patients having focal-onset seizures not adequately controlled despite a history of treatment with at least 2 ASM.

The patients should be eligible to start a treatment with ASM as adjunctive therapy.The patients will be prospectively observed up to 12 months after having completed the related titration.

ASM as adjunctive therapy

Intervention Type: OTHER

ASM approved as adjunctive therapy

Interventions

ASM as adjunctive therapy

ASM approved as adjunctive therapy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hippocrates Research

OTHER

Sponsor Role: collaborator

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Milan, , Italy

Countries

Italy

Other Identifiers

169(A)MD21254

Identifier Type: -

Identifier Source: org_study_id