Epidemiology of Narcolepsy Type 1 and Type 2 in Spain

NCT ID: NCT07299097

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-30

Study Completion Date

2026-05-30

Brief Summary

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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

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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

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Narcolepsy Type 1 Narcolepsy Type 2

Keywords

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Drug therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

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

Supplementary Group

Participants with NT1 and NT2 from Spain will undergo an online survey conducted in collaboration with a patient advocacy group.

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Any age, ethnicity and nationality.
3. 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.


1. Confirmation to have a diagnosis of NT1 or NT2 by a specialist.
2. Participants greater than equal to (≥) 18 years or parents of narcolepsy participants under 18 years of age.
3. Any gender, ethnicity or nationality.
4. Residence in Spain.

Exclusion Criteria

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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Central Contacts

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Takeda Contact

Role: CONTACT

Phone: +1-877-825-3327

Email: [email protected]

Other Identifiers

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TAK-861-4006

Identifier Type: -

Identifier Source: org_study_id