Dravet Syndrome (DS)DRALEGANCT05982717
A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain
An observational study of Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), run by Takeda at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- How many people
- 237 participants
- Where
- 4 sitesSpain
- Study dates
- 26 Oct 2023to 10 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants diagnosed with DS or LGS at public hospitals in Spain will be enrolled in the study.
Who may be able to join
- Diagnosis criteria for DS:
- All the following criteria must be met: i. Seizures onset within 1-20 months (usually within the first year of life). ii. Normal initial development prior to presentation (no cognitive or behavioural disability before the onset of seizures) followed by behaviour and cognitive impairment.
- Recurrent focal clonic (hemiclonic) febrile and afebrile seizures (which often alternate sides from seizure to seizure), focal to bilateral tonicclonic, and/or generalized clonic seizures.
- And at least one of the following criteria must be met: i. Emergence of other seizure type, including atypical absence seizures, myoclonic seizures, atonic seizures, or non-tonic-clonic status epilepticus between 1-4 years.
- Seizures triggered by fever due to illness or vaccinations, hot baths, sudden temperature changes, high level of activity, or by strong lighting or exposure to certain visual patterns.
- Mutations or copy number variants in the SCN1A gene.
Show all 17Show fewer
- Diagnosis criteria for LGS:
- Given the uncertainties associated with the diagnosis of this condition, two different criteria will be used, a stricter criterion, intended to identify "pure" Lennox-Gastaut syndrome participants, and a wider criterion, intended to also include the so-called Lennox-Gastaut-like participants.
- Lennox-Gastaut syndrome - stricter criteria:
- All the following criteria must be met: i. Seizures onset before 18 years of age, typically from 1 to 8 years. ii. Progressive development/cognition impairment after seizures onset. iii. Tonic seizures. iv. At least one additional seizure: generalised tonic-clonic seiures, atypical absence seizures, atonic seizures, myoclonic seizures, focal impaired awareness, epileptic spams, or non-convulsive status epilepticus v. Slow (<2.5 hertz [Hz]) spike-and-wave EEG pattern. vi. Paroxysmal fast activity (10 Hz or greater) in sleep.
- Lennox-Gastaut syndrome - wider criteria:
- At least one the following criteria must be met:
- Tonic seizures. ii. Multiple types of seizures, including generalised tonic-clonic seizures, atypical absence seizures, atonic seizures, myoclonic seizures, myoclonic-atonic seizures, focal seizures, epileptic spams, or nonconvulsive status epilepticus.
- And at least one the following criteria must be met:
- Slow (<2.5 Hz) spike-and-wave EEG pattern. ii. Paroxysmal fast activity (10 Hz or greater) in sleep.
- And at least two of the following criteria must be met:
- Seizures onset before 18 years of age, typically from 1 to 8 years. ii. Progressive development/cognition impairment after seizures onset. iii. Development/cognition impairment starts prior to seizures onset. iv. History of Infantile epileptic spasms syndrome (IESS), West or Ohtahara syndromes.
Who cannot join
- Participants with epileptic condition other than DS or LGS.
- Participants with DS or LGS not residents in the reference area of the hospital.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
H. Universitario Infantil Niño Jesús
Madrid, 28009
H. Universitario La Paz
Madrid, 28046
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36312
About this study
Official title: Epidemiology of Dravet and Lennox-Gastaut Syndromes in Spain
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Epilepsies, Myoclonic, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
As this is an observational study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants With DS or LGS | Participants with a medical record of diagnosis with either DS or LGS that are treated in the participating hospitals and reside in the reference area of these hospitals will be included and data will be retrospectively collected for the period between 01 January 2021 to 31 December 2022. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Year Period Prevalence of DS
Number of participants with DS over a period of one year will be assessed.
Measured: Up to 12 months
Incidence of DS
Number of new participants diagnosed annually with DS yearly.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion
Number of participants with LGS over a period of one year based on stricter diagnosis criterion will be assessed.
Measured: Up to 12 months
Incidence of LGS Based on Stricter Diagnosis Criterion
Number of new participants diagnosed annually with LGS based on stricter diagnosis criterion.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Secondary outcomes (28)
One-Year Period Prevalence of LGS Based on Wider Diagnosis Criterion
Number of participants with LGS over a period of one year based on wider diagnosis criterion will be assessed.
Measured: Up to 12 months
Incidence of LGS Based on Wider Diagnosis Criterion
Number of new participants diagnosed annually with LGS based on wider diagnosis criterion.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
One-Year Period Prevalence of Paediatric DS
Number of participants with paediatric DS over a period of one year will be assessed.
Measured: Up to 12 months
One-Year Period Prevalence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
Number of participants with paediatric LGS over a period of one year based on stricter and wider diagnoses criteria will be assessed.
Measured: Up to 12 months
One-Year Period Prevalence of Adult DS
Number of participants with adult DS over a period of one year will be assessed.
Measured: Up to 12 months
One-Year Period Prevalence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
Number of participants with adult LGS over period of one year based on stricter and wider diagnoses criteria will be assessed.
Measured: Up to 12 months
Incidence of Paediatric DS
Number of new paediatric participants diagnosed annually with DS.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
Number of new paediatric participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Adult DS
Number of new adult participants diagnosed annually with DS.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
Number of new adult participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Gender Distribution
Measured: Up to 12 months
LGS Categorized Based on Gender Distribution According to Stricter and Wider Diagnoses Criteria
Measured: Up to 12 months
DS Categorized Based on Age Distribution
Measured: Up to 12 months
LGS Categorized Based on Age Distribution According to Stricter and Wider Diagnoses Criteria
Measured: Up to 12 months
DS Categorized Based on Gender Distribution at Diagnosis
Annually diagnosed DS participants will be categorized based on gender distribution at diagnosis.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Gender Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
Annually diagnosed LGS participants will be categorized based on gender distribution at diagnosis.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Age Distribution at Diagnosis
Annually diagnosed DS participants will be categorized based on age distribution at diagnosis.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Age Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
Annually diagnosed LGS participants will be categorized based on age distribution at diagnosis.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Gender Distribution at Symptoms Onset
Annually diagnosed DS participants will be categorized based on gender distribution at symptoms onset.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Gender Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
Annually diagnosed LGS participants will be categorized based on gender distribution at symptoms onset.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Age Distribution at Symptoms Onset
Annually diagnosed DS participants will be categorized based on age distribution at symptoms onset.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Age Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
Annually diagnosed LGS participants will be categorized based on age distribution at symptoms onset.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Diagnosis Delay for Participants With DS
Diagnosis delay is defined as time from symptoms onset to diagnosis.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Diagnosis Delay for Participants With LGS Based on Stricter and Wider Diagnoses Criteria
Diagnosis delay is defined as time from tonic seizures onset to electroencephalography (EEG) confirmation.
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With DS: Ratio of Participants Genetically (Sodium Channel Protein Type 1 Subunit Alpha [SCN1A] Mutation) and Clinically Diagnosed Versus Participants Clinically Diagnosed Only
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With LGS: Number of Participants Distributed According to Aetiologies Based on Stricter and Wider Diagnoses Criteria
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With DS: Number of Participants With Different Types of Comorbidities at Diagnosis
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With LGS: Number of Participants With Different Types of Comorbidities at Diagnosis Based on Stricter and Wider Diagnoses Criteria
Measured: At two different 12 month periods (in consecutive years at Months 12 and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start26 Oct 2023
- Primary completion9 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet Syndrome (DS)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982717
- Sponsor's protocol ID
- TAK-935-5003
- Acronym
- DRALEGA
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Dravet and Lennox-Gastaut Syndromes in Spain
- ClinicalTrials.gov ID
- NCT05982717
- Acronym / sponsor ID
- DRALEGA / TAK-935-5003
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With DS or LGS | – | Other: No interventionParticipants with a medical record of diagnosis with either DS or LGS that are treated in the participating hospitals and reside in the reference area of these hospitals will be included and data will be retrospectively collected for the period between 01 January 2021 to 31 December 2022. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants diagnosed with DS or LGS at public hospitals in Spain will be enrolled in the study.
Key inclusion criteria (17 listed)
- Diagnosis criteria for DS:
- All the following criteria must be met: i. Seizures onset within 1-20 months (usually within the first year of life). ii. Normal initial development prior to presentation (no cognitive or behavioural disability before the onset of seizures) followed by behaviour and cognitive impairment.
- Recurrent focal clonic (hemiclonic) febrile and afebrile seizures (which often alternate sides from seizure to seizure), focal to bilateral tonicclonic, and/or generalized clonic seizures.
- And at least one of the following criteria must be met: i. Emergence of other seizure type, including atypical absence seizures, myoclonic seizures, atonic seizures, or non-tonic-clonic status epilepticus between 1-4 years.
- Seizures triggered by fever due to illness or vaccinations, hot baths, sudden temperature changes, high level of activity, or by strong lighting or exposure to certain visual patterns.
Key exclusion criteria (2 listed)
- Participants with epileptic condition other than DS or LGS.
- Participants with DS or LGS not residents in the reference area of the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAs this is an observational study, no intervention will be administered. | Other | Participants With DS or LGS |
Primary outcome
One-Year Period Prevalence of DS
Time frame: Up to 12 months
Number of participants with DS over a period of one year will be assessed.
Incidence of DS
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Number of new participants diagnosed annually with DS yearly.
One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion
Time frame: Up to 12 months
Number of participants with LGS over a period of one year based on stricter diagnosis criterion will be assessed.
Incidence of LGS Based on Stricter Diagnosis Criterion
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Number of new participants diagnosed annually with LGS based on stricter diagnosis criterion.
28 secondary outcomes
One-Year Period Prevalence of LGS Based on Wider Diagnosis Criterion
Time frame: Up to 12 months
Incidence of LGS Based on Wider Diagnosis Criterion
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
One-Year Period Prevalence of Paediatric DS
Time frame: Up to 12 months
One-Year Period Prevalence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
Time frame: Up to 12 months
One-Year Period Prevalence of Adult DS
Time frame: Up to 12 months
One-Year Period Prevalence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
Time frame: Up to 12 months
Incidence of Paediatric DS
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Adult DS
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Incidence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Gender Distribution
Time frame: Up to 12 months
LGS Categorized Based on Gender Distribution According to Stricter and Wider Diagnoses Criteria
Time frame: Up to 12 months
DS Categorized Based on Age Distribution
Time frame: Up to 12 months
LGS Categorized Based on Age Distribution According to Stricter and Wider Diagnoses Criteria
Time frame: Up to 12 months
DS Categorized Based on Gender Distribution at Diagnosis
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Gender Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Age Distribution at Diagnosis
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Age Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Gender Distribution at Symptoms Onset
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Gender Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
DS Categorized Based on Age Distribution at Symptoms Onset
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
LGS Categorized Based on Age Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Diagnosis Delay for Participants With DS
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Diagnosis Delay for Participants With LGS Based on Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With DS: Ratio of Participants Genetically (Sodium Channel Protein Type 1 Subunit Alpha [SCN1A] Mutation) and Clinically Diagnosed Versus Participants Clinically Diagnosed Only
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With LGS: Number of Participants Distributed According to Aetiologies Based on Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With DS: Number of Participants With Different Types of Comorbidities at Diagnosis
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Participants With LGS: Number of Participants With Different Types of Comorbidities at Diagnosis Based on Stricter and Wider Diagnoses Criteria
Time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), run by Takeda at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-Year Period Prevalence of DS (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.