Phase
Condition
Epilepsy
Treatment
ASM as adjunctive therapy
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 secondarygeneralization.
Patients should have been eligible to start treatment with ASM as adjunctive therapyaccording 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 3months prior to -the study entry (diary can be paper or electronic, filled in bypatient 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 inaccordance with the ICH GCP guidelines
Exclusion
Exclusion Criteria:
Patients who meet any of the contraindications to the administration of adjunctiveASMs according to their approved SmPC.
Progressive neurological disease, including degenerative CNS diseases andprogressive tumors.
Patients with unstable psychiatric diagnosis that may confound participants' abilityto participate in the study or that may prevent completion of the protocol-specifiedassessments (e.g., in the judgement of the Investigator, pose an appreciable riskfor suicide, including suicidal behavior and ideation within 6 months prior toenrollment, current psychotic disorder, acute mania).
Evidence of clinically significant disease (e.g., cardiac, respiratory,gastrointestinal, renal disease) that in the opinion of the Investigator couldaffect 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 interventionalstudy within 30 days prior to baseline.
Study Design
Study Description
Connect with a study center
Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Milan, 20133
ItalySite Not Available
Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Milan 3173435, 20133
ItalySite Not Available

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