Last updated: May 17, 2023
Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Overall Status: Active - Recruiting
Phase
N/A
Condition
Epilepsy
Treatment
ASM as adjunctive therapy
Clinical Study ID
NCT05867160
169(A)MD21254
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, legalguardian, 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 and progressivetumors.
- 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 risk forsuicide, 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 affectthe 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
Total Participants: 300
Treatment Group(s): 1
Primary Treatment: ASM as adjunctive therapy
Phase:
Study Start date:
May 02, 2023
Estimated Completion Date:
December 31, 2024
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
ItalyActive - Recruiting
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