WithdrawnNot Applicable

A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal

Stopped: Business Decision

0Started 2024-12-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis criteria for DS:
. Diagnosis criteria for LGS:

Exclusion criteria

. Has epileptic condition other than DS or LGS.
. Has DS or LGS not residents in the reference area of the hospital.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

One-Year Period Prevalence of DS

Timeframe: Up to 12 months

Incidence of DS

Timeframe: At two different 12 months periods (in consecutive years at Months 12 and 24)

One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion

Timeframe: Up to 12 months

Incidence of LGS Based on Stricter Diagnosis Criterion

Timeframe: At two different 12 months periods (in consecutive years at Months 12 and 24)

Trial details

NCT IDNCT06395792

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Dravet Syndrome (DS) trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis criteria for DS:
. Diagnosis criteria for LGS:

Exclusion criteria

. Has epileptic condition other than DS or LGS.
. Has DS or LGS not residents in the reference area of the hospital.

What they're measuring

One-Year Period Prevalence of DS

Timeframe: Up to 12 months

Incidence of DS

Timeframe: At two different 12 months periods (in consecutive years at Months 12 and 24)

One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion

Timeframe: Up to 12 months

Incidence of LGS Based on Stricter Diagnosis Criterion

Timeframe: At two different 12 months periods (in consecutive years at Months 12 and 24)