NCT05982717

A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain

Epidemiology of Dravet and Lennox-Gastaut Syndromes in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 237 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main aims of this study are to gather information about how many children, teenagers and adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in persons in Spain. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care in public hospitals in Spain between 01 January 2021 and 31 December 2022.

Detailed description

This is a non-interventional, retrospective study of participants from Spain with DS and 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 Spain. 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.

Conditions

• Dravet Syndrome (DS)
• Lennox-Gastaut Syndrome (LGS)

Interventions

Type	Name	Description
OTHER	No intervention	As this is an observational study, no intervention will be administered.

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-04-09
• Completion: 2025-04-10
• First posted: 2023-08-09
• Last updated: 2025-04-17

Locations

4 sites across 1 country: Spain