N/A
N=210
A Study to Collect Information of People With Narcolepsy in Spain
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT04667338 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit — 5.10; 7.55; 94.90; 92.45 percentage of participants — p==0.5061
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit |
5.10; 7.55; 94.90; 92.45; 6.37; 1.89 | =0.5061 |
| PRIMARY Percentage of Participants Categorized Based on Non-Pharmacological Treatments Patterns by Treatment Status |
0; 5.56; 100; 94.44 | =0.4016 |
| PRIMARY Percentage of Treated or Naïve (Untreated) Participants for the Type of Pharmacological Treatment Status Since Diagnosis |
5.10; 7.55; 94.90; 92.45 | — |
| PRIMARY Percentage of Participants With the Use of Each Type of Treatment Stratified by Type of Hospital (Public or Private Centers) |
30.60; 18.92; 63.43; 91.89; 63.43; 5.41 | — |
| SECONDARY Number of Participants Categorized by Sociodemographic and Clinical Variables at Study Visit |
157; 53; 78; 31; 79; 22 | =0.5274 |
| SECONDARY Height of Participants at Study Visit |
168.6; 171.0 | — |
| SECONDARY Weight of Participants at Study Visit |
77.45; 77.17 | — |
| SECONDARY Body Mass Index (BMI) of Participants at Study Visit |
27.18; 26.34 | — |
| SECONDARY Blood Pressure (BP) of Participants at Study Visit |
121.0; 120.0; 75.7; 74.3 | — |
| SECONDARY Percentage of Participants Categorized Based on Different Specialists Who Diagnosed Narcolepsy |
1.28; 5.66; 37.18; 24.53; 1.92; 0 | =0.0715 |
| SECONDARY Percentage of Participants Categorized Based on Usage of Different Procedures or Tests for the Diagnosis of Narcolepsy |
91.08; 84.91; 54.14; 58.49; 59.87; 43.40 | =0.2042 |
| SECONDARY Time From First Symptom to Diagnosis of Narcolepsy |
6.30; 2.94 | =0.1171 |
| SECONDARY Time From Diagnosis of Narcolepsy to First Treatment |
0.05; 0.02 | =0.3834 |
| SECONDARY Percentage of Participants Categorized Based on Pharmacological Treatment and Interventions Received in Relation With the Presence of Most Typical Symptoms |
— | — |
| SECONDARY Percentage of Participants With Pharmacological Treatments at Each Line |
82.80; 90.57; 12.10; 1.89; 94.90; 92.45 | — |
| SECONDARY Sustained Attention to Response Task (SART) |
— | — |
| SECONDARY Maintenance of Wakefulness Test (MWT) |
— | — |
| SECONDARY Epworth Sleepiness Scale (ESS) |
18.08; 16.35 | =0.0531 |
| SECONDARY Percentage of Participants Categorized Based on Different Non-pharmacological Treatment Approach |
79.62; 60.38; 68.15; 69.81; 56.69; 47.17 | =0.0005 sig |
| SECONDARY Percentage of Participants Categorized Based on Utilization of Direct Healthcare Resource Utilized Per Year |
89.81; 86.79; 78.34; 64.15; 78.98; 64.15 | =0.5432 |
| SECONDARY Duration of Hospitalization |
1.00 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI) Score |
11.57; 3.23; 32.4; 28.1; 34.63; 29.54 | =0.0034 sig |
| SECONDARY Number of Participants Categorized Based on Occupational Accidents |
131; 51; 8; 2 | =0.5806 |
| SECONDARY Percentage of Participants Categorized Based on Cost of Direct Healthcare Resources Utilized by Participants Per Year |
— | — |
| SECONDARY Percentage of Participants With Health Related Quality of Life (HRQoL) Assessed by European Quality of Life Five Dimension (EQ-5D) Questionnaire |
85.91; 84.91; 8.05; 15.09; 4.70; 0 | =0.1602 |
| SECONDARY Stigma Scale for Chronic Illness 8-item Version (SSCI-8) Total Score |
15.5; 14.1 | =0.0396 sig |
| SECONDARY Treatment Satisfaction of Participants Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) |
67.53; 63.05; 74.21; 73.06; 68.54; 63.36 | =0.0394 sig |
| SECONDARY Percentages of Participants Based on Most Prevalent Comorbidities and Other Concomitant Disorders Associated With Narcolepsy |
14.65; 7.55; 0; 1.89; 12.74; 7.55 | =0.1817 |
| SECONDARY Charlson Comorbidity Index (CCI) |
0.4; 0.2 | =0.3585 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- With confirmed diagnosis of narcolepsy defined by ICDS-3.
- With at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion.
- With data available at the participant site at least 1-year before first narcolepsy diagnosis.
- Capable to fulfill the study questionnaires.
Exclusion Criteria
- Participating in a clinical trial (less than or equal to [<=] 12 months).
- With any serious degenerative disease (Alzheimer, Parkinson or epilepsy) or psychiatric condition.
Data sourced from ClinicalTrials.gov (NCT04667338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.