Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study (NCT05867160) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study
Italy300 participantsStarted 2023-05-02
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 …
What they're measuring
1
Change in seizure frequency at 6 months of maintenance
Timeframe: At 6 months of maintenance compared to baseline
Trial details
NCT IDNCT05867160
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A