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NCT07903220

A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The usual care for NT1 focuses on managing symptoms and improving the sleep and wake cycle. It pays special attention to daytime sleepiness. Information on treatment use and related effects in adults with NT1 is limited. This study aims to collect such information and help fill this gap. The main aim of this study is to better understand how adults with NT1 are treated in real life, why treatment changes happen and how different treatment choices (both medicines and non-medicine strategies) affect symptoms, cataplexy and quality of life over time. The study also aims to learn more about adults with NT1, how they are diagnosed, how their treatment works, and how often they need medical care. It will also record how satisfied they are with treatment and how NT1 affects their symptoms, daily life, and quality of life over time.

Official title: Real-World Treatment Patterns in Narcolepsy Type 1: A Retrospective, Cross-Sectional and Prospective, Observational Study in Europe and Canada

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-12-20

Completion Date

2027-09-30

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Narcolepsy Type 1

Interventions

OTHER

No intervention

This is a non-interventional study.

Criteria for the Retrospective Cohort with a Cross-Sectional Survey Component Inclusion Criteria 1. Agrees and is able to provide signed informed consent. 2. Has a documented diagnosis of NT1, established according to internationally recognized diagnostic criteria (e.g., International Classification of Sleep Disorders \[ICSD\] or equivalent European/national guidelines). 3. Is between 18 and 70 years of age (inclusive) at enrollment. 4. Initiated any pharmacotherapy for narcolepsy within the 5 years prior to enrollment. 5. Has reliable internet access and is willing to complete the cross-sectional survey. Exclusion Criteria 1. Has a current medical condition associated with EDS other than NT1. 2. Has participated in a narcolepsy investigational drug clinical trial involving an orexin receptor agonist during the retrospective observation period. Criteria for the Prospective Cohort Inclusion criteria 1. Agrees and is able to provide signed informed consent. 2. Has a documented diagnosis of NT1, established according to internationally recognized diagnostic criteria (e.g., ICSD or equivalent European/national guidelines). 3. Is between 18 and 70 years of age (inclusive) at enrollment. 4. Is planning to initiate treatment with pitolisant or sodium oxybate (as monotherapy or in combination with other narcolepsy pharmacotherapies) to treat symptoms associated with NT1 on the day of or within 28 days after enrollment. 5. Has an ESS total score greater than or equal to (≥) 11 within 14 days prior to or at enrollment. 6. Participants must meet one of the following: • Currently treated Participants: The participant has been receiving an anti-cataplexy medication for ≥ 2 months prior to enrollment and had a historical WCR ≥ 4 (partial or complete episodes) prior to initiating the anticataplexy treatment; or • Treatment-naïve participants: The participant is naïve to narcolepsy treatment at enrollment and has a WCR ≥ 4 (partial or complete episodes) within 14 days prior to or on the day of enrollment 7. Has reliable internet access and is willing to complete ePROs/e-diary for the duration of the study. Exclusion criteria 1. Has a current medical condition other than NT1 associated with EDS. 2. Has any severe or unstable psychiatric disorder, or active major depressive episode within 6 months prior to or at enrollment, as assessed by the investigator. 3. Is participating in a narcolepsy investigational drug clinical trial involving an orexin receptor agonist at study enrollment. 4. Has any significant medical condition that, in the judgment of the treating physician, may compromise follow-up or study participation.