Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

NCT07299097 | Recruiting

• 1 other identifier: TAK-861-4006
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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. The researchers will look at medical records from hospitals across Spain to count participants with these conditions and understand patterns in diagnosis over time.

Conditions

Narcolepsy Type 2; Narcolepsy Type 1

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Up to approximately 10 years

• Core Group: Proportion of Participants as per Age with NT1 and NT2 at Diagnosis

  Up to approximately 10 years

• Core Group: Proportion of Participants as per Gender with NT1 and NT2 at Symptom Onset

  Up to approximately 10 years

• Core Group: Proportion of Participants as per Age with NT1 and NT2 at Symptom Onset

  Up to approximately 10 years

• Core Group: Percentage Change in NT1 and NT2 Prevalence Over Past 10 Years

  Up to 10 years

Study Arms (2)

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.

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.

Other: No intervention

Interventions

No intervention OTHER

As this is an observational study, no intervention will be administered.

Core Group; Supplementary Group

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with NT1 and NT2 from Spain.

You may qualify if:

• 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.

You may not qualify if:

• \. NT1 or NT2 participants who do not reside in the hospitals' reference areas.
• \- Supplementary Group:
• 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.
• \. Participants without a confirmed NT1 or NT2 diagnosis by a specialist.

Sponsors & Collaborators

• Takeda: lead

Study Sites (10)

Hospital General de Castellón

Castellon, Castellon, 12004, Spain

NOT YET RECRUITING

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Hospital de la Ribera

Alzira, Valencia, 46600, Spain

NOT YET RECRUITING

Hospital Vall d'Hebrón

Barcelona, 8035, Spain

NOT YET RECRUITING

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

RECRUITING

Hospital Virgen de las Nieves

Granada, 18014, Spain

NOT YET RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

ACTIVE NOT RECRUITING

Hospital La Paz

Madrid, 28046, Spain

NOT YET RECRUITING

Hospital Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital de Araba

Vitoria-Gasteiz, Álava, 1009, Spain

NOT YET RECRUITING

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

ES (10)