Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 7:00 AM
Study NCT ID:
NCT06395792
Status:
WITHDRAWN
Last Update Posted:
2024-10-03
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Epidemiology of Dravet and Lennox-Gastaut Syndromes in Portugal
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRALEGA-PT
Brief Summary:
The main aim of this study is to learn about the percentage of persons diagnosed with Dravet Syndrome (DS) and Lennox-Gastaut-Syndrome (LGS) in 2022 and of persons newly diagnosed in 2021 and 2022 compared to the overall population in Portugal. Other aims are to understand how many percent of the persons diagnosed with DS and LGS are children, teenagers or adults and gather additional information on diagnosis and persons diagnosed with DS and LGS in Portugal.
Information will be taken from a participant's existing medical hospital records. It is planned to review data in approximately 3 public hospitals in Portugal. No personal information of the participants will be collected.
Information will be taken from a participant's existing medical hospital records. It is planned to review data in approximately 3 public hospitals in Portugal. No personal information of the participants will be collected.
Detailed Description:
This is a non-interventional, multicentre, cross-sectional retrospective study of participants from Portugal with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) at public hospitals. The participants will be identified from their medical charts or hospital records and those who meet the eligibility criteria will be included.
This multi-center trial will be conducted in Portugal. Data will be retrospectively collected for the observation period between 01 January 2021 to 31 December 2022. The total duration of the study is approximately 24 months.
This multi-center trial will be conducted in Portugal. Data will be retrospectively collected for the observation period between 01 January 2021 to 31 December 2022. The total duration of the study is approximately 24 months.
Study Oversight
Has Oversight DMC:
False
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?: