Narcolepsy Type 1HYPNOSNCT07299097
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
An observational study of Narcolepsy Type 1 and Narcolepsy Type 2, run by Takeda at 10 sites in Spain.
Trial summary
The main purpose of this study is to find out how many people in Spain have been diagnosed with narcolepsy type 1 and type 2, and how many new participants are diagnosed each year. Narcolepsy is a rare sleep disorder that causes excessive daytime sleepiness. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Narcolepsy Type 1, Narcolepsy Type 2
- How many people
- 402 participants
- Where
- 10 sitesSpain
- Study dates
- 2 Dec 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with NT1 and NT2 from Spain.
Who may be able to join
- Participants with NT1 or NT2 following International Classification of Sleep Disorders, 3rd Edition (ICSD-3) or ICSD-3 text revision (ICSD-3-TR) criteria who are alive at any point during 2023 or 2024.
- Any age, ethnicity and nationality.
- Treated / under follow-up in the study site and residing in the hospitals' reference areas. Consideration will be given if participants have changed their address or reached adulthood.
- Confirmation to have a diagnosis of NT1 or NT2 by a specialist.
- Participants greater than equal to (≥) 18 years or parents of narcolepsy participants under 18 years of age.
- Any gender, ethnicity or nationality.
- Residence in Spain.
Who cannot join
- 1. NT1 or NT2 participants who do not reside in the hospitals' reference areas.
- Supplementary Group:
- 1. Participants without a confirmed NT1 or NT2 diagnosis by a specialist.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital de la Ribera
Alzira, Valencia, 46600
Hospital Vall d'Hebrón
Barcelona, 8035
Hospital Clinic de Barcelona
Barcelona, 8036
Hospital General de Castellón
Castellon, Castellon, 12004
Hospital Virgen de las Nieves
Granada, 18014
Hospital Clínico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Virgen Macarena
Seville, 41009
Hospital de Araba
Vitoria-Gasteiz, Álava, 1009
About this study
The main purpose of this study is to find out how many people in Spain have been diagnosed with narcolepsy type 1 and type 2, and how many new participants are diagnosed each year. Narcolepsy is a rare sleep disorder that causes excessive daytime sleepiness. The researchers will look at medical records from hospitals across Spain to count participants with these conditions and understand patterns in diagnosis over time.
Read the detailed description
The aim is to do epidemiology study in the core group thus the enrolment number is not applicable to this group, however approximately100 participants in the supplementary group (online survey).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2
- Being tested
- No intervention
- Keywords
- Drug therapy
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 |
|---|---|---|
| Core Group | Participants with Narcolepsy Type (NT1) and Narcolepsy Type (NT2) of any age, ethnicity and nationality, treated / under follow-up in approximately 10 Spanish public hospitals, who are alive at any point during 2023 or 2024, residing in the hospitals' reference areas will be retrospectively observed through chart reviews. The retrospective data for up to approximately 10 years would be assessed. Receives: Other: No intervention | |
| Supplementary Group | Participants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population
The overall study prevalence will be calculated as the number of participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Measured: Up to 1 year
Core Group: Prevalence of Adult Participants With NT1 and NT2 per 100,000 Adult Population
The overall study prevalence will be calculated as the number of adult participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of adult people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Measured: Up to 1 year
Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population
The overall study prevalence will be calculated as number of diagnosed paediatric/adolescent participants from all public hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Measured: Up to 1 year
Core Group: Prevalence of Male Participants With NT1 and NT2 per 100,000 Male Population
The overall study prevalence will be calculated as the number of male participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of males living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Measured: Up to 1 year
Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population
The overall study prevalence will be calculated as the number of female participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of females living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Measured: Up to 1 year
Core Group: Incidence of NT1 and NT2 per 100,000 Population
The incidence for both the years will be calculated as (average of both years). And for each year, the number of participants diagnosed for the first time from all hospitals divided by number of people living in the areas served by the hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Measured: Up to 2 years
Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population
The incidence for both the years will be calculated as (average of both years) and for each year, the number of adult participants diagnosed for the first time from all hospitals divided by number of adults living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Measured: Up to 2 years
Core Group: Incidence of Paediatric/Adolescent NT1 and NT2 per 100,000 Paediatric/Adolescent Population
The incidence for both the years will be calculated as (average of both years) and for each year, the number of paediatric/adolescent participants diagnosed for the first time from all hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Measured: Up to 2 years
Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population
The incidence for both the years will be calculated as (average of both years) and for each year, the number of male participants diagnosed for the first time from all hospitals divided by number of male participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Measured: Up to 2 years
Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population
The incidence for both the years will be calculated as (average of both years) and for each year, the number of female participants diagnosed for the first time from all hospitals divided by number of female participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Measured: Up to 2 years
Supplementary Group: Number of Participants with NT1 and NT2 who Attend Regular Follow-ups
Proportion of Participants with NT1 and NT2 in Spain who attended regular follow ups at only public hospitals, only private hospitals, and both private and public hospitals will be reported.
Measured: On a day of survey (any 1 day) during the study for each participant
Secondary outcomes (30)
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis
Measured: Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis
Measured: Up to approximately 10 years
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset
Measured: Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset
Measured: Up to approximately 10 years
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years
The overall prevalence will be calculated as the number of participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of people living in the areas served by these hospitals resulting in prevalence fraction. The overall percentage change of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Percentage Change in Adult With NT1 and NT2 Prevalence Over Past 10 Years
The overall prevalence will be calculated as the number of adult participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of adult people living in the areas served by these hospitals resulting in a study prevalence fraction. The overall percentage change of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years
The overall prevalence will be calculated as the number of paediatric/adolescent participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study prevalence fraction. The overall percentage of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years
The incidence will be calculated as number of participants diagnosed for the first time from all hospitals divided by number of people living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage change of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years
The incidence will be calculated as number of adult participants diagnosed for the first time from all hospitals divided by number of adults living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage change of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Incidence Over Past 10 Years
The incidence will be calculated as number of paediatric/adolescent participants diagnosed for the first time from all hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study incidence fraction. The overall percentage of participant resulting from the above method will be reported.
Measured: Up to 10 years
Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Measured: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Measured: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Paediatric/Adolescent Participants with NT1 and NT2
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Measured: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Male Participants with NT1 and NT2
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Measured: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Female Participants with NT1 and NT2
Diagnostic delay means that cases that began to present symptoms in the years prior to one year and have not yet been diagnosed.
Measured: Up to approximately 10 years
Core Group: Percentage Change in Diagnostic Delay for Participants With NT1 and NT2 Over Past 10 Years
Measured: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 10 Years
Measured: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Paediatric/Adolescent Participants With NT1 and NT2 Over Past 10 Years
Measured: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years
Measured: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years
Measured: Up to 10 years
Supplementary Group: Proportion of Participants With NT1 and NT2 who Were Diagnosed at Public hospitals and Private Practices
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Group: Proportion of Participants who Choose to be Followed in Public, Private, or Both Types of Hospitals and Reasons
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Symptom Onset
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Diagnosis
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor Visited First for Narcolepsy Symptoms
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor who Diagnosed Narcolepsy
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Number of Doctors Visited by Participant Prior to Receiving a Narcolepsy Diagnosis
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants With Misdiagnosis Prior to Narcolepsy Diagnosis
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants with Comorbidities
Measured: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Place of Residence (Autonomous Community)
Measured: On a day of survey (any 1 day) during the study for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start2 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299097
- Sponsor's protocol ID
- TAK-861-4006
- Acronym
- HYPNOS
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2025
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
- ClinicalTrials.gov ID
- NCT07299097
- Acronym / sponsor ID
- HYPNOS / TAK-861-4006
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 402 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (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 purpose of this study is to find out how many people in Spain have been diagnosed with narcolepsy type 1 and type 2, and how many new participants are diagnosed each year. Narcolepsy is a rare sleep disorder that causes excessive daytime sleepiness. The researchers will look at medical records from hospitals across Spain to count participants with these conditions and understand patterns in diagnosis over time.
Detailed description
The aim is to do epidemiology study in the core group thus the enrolment number is not applicable to this group, however approximately100 participants in the supplementary group (online survey).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Group | – | Other: No interventionParticipants with Narcolepsy Type (NT1) and Narcolepsy Type (NT2) of any age, ethnicity and nationality, treated / under follow-up in approximately 10 Spanish public hospitals, who are alive at any point during 2023 or 2024, residing in the hospitals' reference areas will be retrospectively observed through chart reviews. The retrospective data for up to approximately 10 years would be assessed. |
| Supplementary Group | – | Other: No interventionParticipants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with NT1 and NT2 from Spain.
Key inclusion criteria (7 listed)
- Participants with NT1 or NT2 following International Classification of Sleep Disorders, 3rd Edition (ICSD-3) or ICSD-3 text revision (ICSD-3-TR) criteria who are alive at any point during 2023 or 2024.
- Any age, ethnicity and nationality.
- Treated / under follow-up in the study site and residing in the hospitals' reference areas. Consideration will be given if participants have changed their address or reached adulthood.
- Confirmation to have a diagnosis of NT1 or NT2 by a specialist.
- Participants greater than equal to (≥) 18 years or parents of narcolepsy participants under 18 years of age.
Key exclusion criteria (3 listed)
- 1. NT1 or NT2 participants who do not reside in the hospitals' reference areas.
- Supplementary Group:
- 1. Participants without a confirmed NT1 or NT2 diagnosis by a specialist.
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 | Core Group, Supplementary Group |
Primary outcome
Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population
Time frame: Up to 1 year
The overall study prevalence will be calculated as the number of participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Core Group: Prevalence of Adult Participants With NT1 and NT2 per 100,000 Adult Population
Time frame: Up to 1 year
The overall study prevalence will be calculated as the number of adult participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of adult people living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Core Group: Prevalence of Paediatric/Adolescent Participants With NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Time frame: Up to 1 year
The overall study prevalence will be calculated as number of diagnosed paediatric/adolescent participants from all public hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Core Group: Prevalence of Male Participants With NT1 and NT2 per 100,000 Male Population
Time frame: Up to 1 year
The overall study prevalence will be calculated as the number of male participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of males living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Core Group: Prevalence of Female Participants With NT1 and NT2 per 100,000 Females Population
Time frame: Up to 1 year
The overall study prevalence will be calculated as the number of female participants diagnosed with NT1 and NT2 from all public hospitals reporting cases divided by number of females living in the areas served by these hospitals resulting in a study prevalence fraction. The study prevalence fraction will be then extrapolated to the Spanish population to estimate the standardized overall prevalence of NT1 and NT2 in Spain.
Core Group: Incidence of NT1 and NT2 per 100,000 Population
Time frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years). And for each year, the number of participants diagnosed for the first time from all hospitals divided by number of people living in the areas served by the hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Core Group: Incidence of NT1 and NT2 per 100,000 Adult Population
Time frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of adult participants diagnosed for the first time from all hospitals divided by number of adults living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Core Group: Incidence of Paediatric/Adolescent NT1 and NT2 per 100,000 Paediatric/Adolescent Population
Time frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of paediatric/adolescent participants diagnosed for the first time from all hospitals divided by number of paediatric/adolescent living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Core Group: Incidence of Male NT1 and NT2 per 100,000 Male Population
Time frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of male participants diagnosed for the first time from all hospitals divided by number of male participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Core Group: Incidence of Female NT1 and NT2 per 100,000 Female Population
Time frame: Up to 2 years
The incidence for both the years will be calculated as (average of both years) and for each year, the number of female participants diagnosed for the first time from all hospitals divided by number of female participants living in the areas served by these hospitals resulting in a study incidence fraction. The study incidence fraction will be then extrapolated to the Spanish population to estimate the standardized overall incidence of NT1 and NT2 in Spain.
Supplementary Group: Number of Participants with NT1 and NT2 who Attend Regular Follow-ups
Time frame: On a day of survey (any 1 day) during the study for each participant
Proportion of Participants with NT1 and NT2 in Spain who attended regular follow ups at only public hospitals, only private hospitals, and both private and public hospitals will be reported.
30 secondary outcomes
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Diagnosis
Time frame: Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis
Time frame: Up to approximately 10 years
Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset
Time frame: Up to approximately 10 years
Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset
Time frame: Up to approximately 10 years
Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Adult With NT1 and NT2 Prevalence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Prevalence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in NT1 and NT2 Incidence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Adult NT1 and NT2 Incidence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Paediatric/Adolescent NT1 and NT2 Incidence Over Past 10 Years
Time frame: Up to 10 years
Core Group: Diagnostic Delay for Incident Participants with NT1 and NT2
Time frame: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Adult Participants with NT1 and NT2
Time frame: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Paediatric/Adolescent Participants with NT1 and NT2
Time frame: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Male Participants with NT1 and NT2
Time frame: Up to approximately 10 years
Core Group: Diagnostic Delay for Incident Female Participants with NT1 and NT2
Time frame: Up to approximately 10 years
Core Group: Percentage Change in Diagnostic Delay for Participants With NT1 and NT2 Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Adult Participants With NT1 and NT2 Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Paediatric/Adolescent Participants With NT1 and NT2 Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Male Participants With NT1 and NT2 Over Past 10 Years
Time frame: Up to 10 years
Core Group: Percentage Change in Diagnostic Delay for Female Participants With NT1 and NT2 Over Past 10 Years
Time frame: Up to 10 years
Supplementary Group: Proportion of Participants With NT1 and NT2 who Were Diagnosed at Public hospitals and Private Practices
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Group: Proportion of Participants who Choose to be Followed in Public, Private, or Both Types of Hospitals and Reasons
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Symptom Onset
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Age at Diagnosis
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor Visited First for Narcolepsy Symptoms
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Speciality of the Doctor who Diagnosed Narcolepsy
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Number of Doctors Visited by Participant Prior to Receiving a Narcolepsy Diagnosis
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants With Misdiagnosis Prior to Narcolepsy Diagnosis
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants with Comorbidities
Time frame: On a day of survey (any 1 day) during the study for each participant
Supplementary Study: Proportion of Participants as per Place of Residence (Autonomous Community)
Time frame: On a day of survey (any 1 day) during the study for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy Type 1 and Narcolepsy Type 2, run by Takeda at 10 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
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?
Core Group: Prevalence of Participants With NT1 and NT2 per 100,000 Population (time frame: Up to 1 year). The study lists 11 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 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.