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NCT05867160Active, not recruiting

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

A 12-month, Prospective, Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting

Source: ClinicalTrials.gov · Last updated 10 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
21 Mar 2023
Start date
2 May 2023
Primary completion date
30 Sept 2025
Lead sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Diseases
Epilepsy
NCT number
NCT05867160

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 2 May 2023 to the primary completion date, 30 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.

Other illness

  • Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
  • 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.

Other

  • Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
  • Patients with substance abuse or dependence (except for caffeine and nicotine).

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.