Clinical Trials Logo
  1. Home
  2. Narcolepsy
  3. NCT05615584

Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence — MRM-OREX  

Narcolepsy Clinical Trial

Official title:
Multiple Reaction Monitoring (MRM) Versus I 125 Radioimmunoassay (RIA) for the Quantification of Orexin-A/Hypocretin-1 Levels in Cerebrospinal Fluid: a Prospective Diagnostic Validation Study in Patients With Hypersomnolence

Clinical Trial Summary

In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome. The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria. The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05615584
Study type Interventional
Source University Hospital, Montpellier
Contact
Status Recruiting
Phase N/A
Start date February 15, 2023
Completion date October 30, 2025
View Details
See also
  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Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1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'