A Study to Collect Information of People With Narcolepsy in Spain (SOMNUS)

Takeda

Status: Completed

Conditions: Narcolepsy

Study type: Observational

Funder types: Industry

Identifiers

NCT04667338

U1111-1259-8720 (Registry Identifier)

TAK-994-5001

Details and patient eligibility

About

This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly. Study doctors will review the medical records of the participants from sleep clinics in Spain. They will do this from 1 year before the participant was diagnosed with narcolepsy up to the start of this study.

Participants will visit the sleep clinic once. During this visit, the study doctors will carry out a short medical exam. Participants will also complete a few questionnaires during this visit. If participants cannot visit the clinic for any reason, the clinic staff will arrange a phone call instead.

Full description

This is a non-interventional, cross-sectional study with retrospective medical chart review conducted in public and private Spanish sleep clinics, to describe the management of adult participants diagnosed with narcolepsy defined by ICDS-3 in real world practice.

This study will enroll approximately 196 participants (137 with NT1 and 59 with NT2). Participants will be enrolled in 2 cohorts:

• Cohort A: NT1 Participants
• Cohort B: NT2 Participants

The data will be collected retrospectively through clinical records and at study visit (clinical and demographic data, and participant related outcomes [PRO]) in an electronic case report form (eCRF).

This multi-center study will be conducted in Spain. The overall duration of this study is approximately 24 months. Participants will attend a single visit in the participating centers. In the event of a possible outbreak of coronavirus disease 2019 (COVID-19) participants will have a telepathic visits, the invitation to participate, the obtention of participant's informed consent and the collection of participant's questionnaires will be carried out remotely (by phone or via email).

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. With confirmed diagnosis of narcolepsy defined by ICDS-3.
2. With at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion.
3. With data available at the participant site at least 1-year before first narcolepsy diagnosis.
4. Capable to fulfill the study questionnaires.

Exclusion criteria

1. Participating in a clinical trial (less than or equal to [<=] 12 months).
2. With any serious degenerative disease (Alzheimer, Parkinson or epilepsy) or psychiatric condition.

Trial design

214 participants in 2 patient groups

Narcolepsy Type 1

Description:

Participants with confirmed diagnosis of narcolepsy type 1 (NT1) defined by the International Classification of Sleep Disorders, Third Edition (ICDS-3) will be observed for up to 16 months.

Narcolepsy Type 2

Description:

Participants with confirmed diagnosis of narcolepsy type 2 (NT2) defined by the ICDS-3 will be observed for up to 16 months.