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

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

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.

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

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.

Connect with a study center

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

    Milan, 20133
    Italy

    Active - Recruiting

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