Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867160
Status:
RECRUITING
Last Update Posted:
2023-05-19
First Post:
2023-03-21
Brief Title:
Adjunctive Anti-seizure Medication ASM Real World Evidence RWE Study
Sponsor:
Aziende Chimiche Riunite Angelini Francesco SpA
Organization:
Aziende Chimiche Riunite Angelini Francesco SpA
Study Overview
Official Title:
A 12-month Prospective Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 physicians judgment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None