A Study to Collect Information of People With Narcolepsy in Spain

NCT04667338 | Completed Results DMC

• 2 other identifiers: TAK-994-5001U1111-1259-8720
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcolepsy

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit

  Percentage of participants with narcolepsy categorized based on pharmacological and non-pharmacological treatment as 'yes' and 'no' since study diagnosis are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point.

  From narcolepsy diagnosis up to study visit (up to 12 months)

• Percentage of Participants Categorized Based on Non-Pharmacological Treatments Patterns by Treatment Status

  Percentage of participants with narcolepsy categorized based on non-pharmacological treatment patterns as 'yes' and 'no' by treatment status \[Naïve (untreated) and treated\] are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point. Data is collected and reported per Naïve (untreated) and treated arms for this outcome measure.

  From narcolepsy diagnosis up to study visit (up to 12 months)

• Percentage of Treated or Naïve (Untreated) Participants for the Type of Pharmacological Treatment Status Since Diagnosis

  Percentage of Treated or naïve (Untreated) participants with narcolepsy categorized based on pharmacological treatment status since diagnosis are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point.

  From narcolepsy diagnosis up to study visit (up to 12 months)

• Percentage of Participants With the Use of Each Type of Treatment Stratified by Type of Hospital (Public or Private Centers)

  Percentages are rounded off to the nearest decimal point.

  From a year before narcolepsy diagnosis up to study visit (up to 20 months)

Secondary Outcomes (26)

• Number of Participants Categorized by Sociodemographic and Clinical Variables at Study Visit

  Day 1

• Height of Participants at Study Visit

  Day 1

• Weight of Participants at Study Visit

  Day 1

• Body Mass Index (BMI) of Participants at Study Visit

  Day 1

• Blood Pressure (BP) of Participants at Study Visit

  Day 1

Study Arms (2)

Narcolepsy Type 1

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

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

Eligibility Criteria

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

Study Population

Participants with confirmed diagnosis of narcolepsy defined by ICDS-3.

You may qualify if:

• With confirmed diagnosis of narcolepsy defined by ICDS-3.
• With data available at the participant site at least 1-year before first narcolepsy diagnosis.
• Capable to fulfill the study questionnaires.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 8036, Spain

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 14, 2020
• Study Start: February 18, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

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 (1)