Narcolepsy Clinical Trial
Official title:
Observational, Multicentre, Cross-sectional Study to Describe Diagnosis and Treatment Patterns in Narcolepsy Patients in Real Life Practice in Spain
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.
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04072380 -
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
|
Phase 2 | |
| Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 | |
| Completed |
NCT02821715 -
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
|
Phase 2 | |
| Completed |
NCT01681121 -
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
|
Phase 2 | |
| Completed |
NCT01789398 -
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
|
Phase 3 | |
| Completed |
NCT00174174 -
Provigil (Modafinil) Study by Taiwan Biotech Co.
|
N/A | |
| Completed |
NCT05059223 -
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
|
Phase 3 | |
| Completed |
NCT04923594 -
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
|
Phase 2 | |
| Recruiting |
NCT06279247 -
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
|
||
| Completed |
NCT04647903 -
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
|
Phase 1 | |
| Completed |
NCT03267303 -
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
|
Phase 2 | |
| Completed |
NCT03173378 -
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
|
||
| Completed |
NCT05055024 -
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
|
Phase 2 | |
| Completed |
NCT01067235 -
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
|
Phase 3 | |
| Completed |
NCT00228566 -
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
|
Phase 3 | |
| Completed |
NCT00132873 -
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
|
Phase 3 | |
| Completed |
NCT00107796 -
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
|
Phase 3 | |
| Completed |
NCT00107848 -
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
|
Phase 3 | |
| Enrolling by invitation |
NCT05113745 -
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy
|
Phase 3 | |
| Suspended |
NCT04419792 -
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
|