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

Angelini Pharma

Status: Active, not recruiting

Conditions: Epilepsy

Treatments: Other: ASM as adjunctive therapy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05867160

169(A)MD21254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

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

Description:

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.

Treatment:

Other: ASM as adjunctive therapy