narcolepsy

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Information
Disease name
narcolepsy
Disease ID
DOID:8986
Description
"A sleep disorder that involves an excessive urge to sleep at inappropriate times, such as while at work." [url:http\://en.wikipedia.org/wiki/Narcolepsy]
Disease area statistics
[No Data.]
Chromosome band
[No Data.]
Annotation
Genes Mutation Description Source Links
NCT ID Status Phase Summary Start date Completion date
NCT01394614 Completed Risk of Narcolepsy Associated With Administration of H1N1 Vaccine June 2011 November 2014
NCT00049803 Completed Phase 3 Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients December 2000 April 2004
NCT00066170 Completed Phase 3 Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy April 2003 November 2004
NCT00078312 Completed Phase 3 Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder January 2004 July 2006
NCT00078377 Completed Phase 3 Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy March 2004 January 2005
NCT00107796 Completed Phase 3 Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy October 2004 September 2005
NCT00107848 Completed Phase 3 PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome October 2004 September 2005
NCT00132873 Completed Phase 3 Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy October 2004 December 2007
NCT00174174 Completed N/A Provigil (Modafinil) Study by Taiwan Biotech Co. September 2003
NCT00214968 Completed Phase 3 Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness January 2005 October 2005
NCT00228553 Completed Phase 3 Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness May 2004 July 2006
NCT00228566 Completed Phase 3 Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome October 2005 July 2006
NCT00244465 Completed Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription May 2006 September 2016
NCT00283894 Completed Body Weight Regulation in Patients With Narcolepsy January 20, 2006 June 19, 2013
NCT02785328 Completed N/A Sleep and Memory in Children February 2016 May 29, 2018
NCT02806908 Completed Phase 2 Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy June 2016 May 19, 2019
NCT02821715 Completed Phase 2 Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients September 2016 February 2019
NCT02832336 Completed Phase 1/Phase 2 The Effect of Caffeine on the Narcoleptic Patients October 1, 2016 May 7, 2018
NCT02913651 Completed Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia January 2016 December 2016
NCT03173378 Completed Evaluation of Academic and Professional Trajectories of Narcoleptic Patients October 3, 2017 July 10, 2018
NCT03267303 Completed Phase 2 A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy October 31, 2017 August 8, 2019
NCT03378453 Completed N/A Narcolepsy Protect Against Alzheimer's Disease? April 7, 2016 November 2017
NCT03748979 Completed Phase 1 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy November 21, 2018 October 24, 2019
NCT03765892 Completed Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE) February 27, 2020 February 27, 2023
NCT03881852 Completed Phase 2 Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) January 30, 2019 November 27, 2019
NCT03904238 Completed N/A Psychosocial Adjunctive Treatment for Hypersomnia (PATH) December 10, 2018 October 7, 2019
NCT04072380 Completed Phase 2 A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy September 21, 2019 June 13, 2023
NCT04141891 Completed N/A Advancing Understanding of Transportation Options December 12, 2019 December 21, 2023
NCT04232644 Completed Phase 1 Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR) May 27, 2019 July 17, 2019
NCT04306952 Completed N/A Awareness and Self-Compassion Enhancing Narcolepsy Treatment June 15, 2020 June 30, 2022
NCT04316286 Completed N/A TElemedicine for NARcolepsy April 1, 2020 May 31, 2023
NCT04451668 Completed Phase 3 An Open Label Study of FT218 in Subjects With Narcolepsy June 12, 2020 December 22, 2023
NCT04647903 Completed Phase 1 Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) October 5, 2020 December 17, 2021
NCT04667338 Completed A Study to Collect Information of People With Narcolepsy in Spain February 24, 2021 November 3, 2022
NCT04794491 Completed Phase 4 An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy March 22, 2021 November 15, 2022
NCT04803786 Completed A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy April 9, 2021 February 24, 2022
NCT04827329 Completed Anesthetic Management of Patients With Chronic Sleep Disorders March 1, 2021 July 1, 2021
NCT04923594 Completed Phase 2 Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy September 13, 2021 June 30, 2022
NCT05008341 Completed Phase 1 Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration August 27, 2021 April 15, 2022
NCT05015673 Completed Phase 1 This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation. June 5, 2014 May 26, 2015
NCT05055024 Completed Phase 2 An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy October 26, 2021 January 19, 2023
NCT05059223 Completed Phase 3 A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy September 15, 2021 March 15, 2024
NCT05709873 Completed N/A Narcolepsy Nightmare Study February 22, 2023 April 30, 2024
NCT00424931 Completed Phase 2 A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy January 2007 December 2007
NCT00916253 Completed N/A Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies March 2010 August 2012
NCT01006122 Completed Phase 2 A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy November 2009 November 2010
NCT01067222 Completed Phase 3 Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy May 2009 December 2010
NCT01067235 Completed Phase 3 Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy October 2009 July 2010
NCT01146600 Completed Phase 2 Clarithromycin for the Treatment of Hypersomnia July 2010 September 2012
NCT00001664 Completed Sleep Disorders of Patients With Diseases of the Nervous System December 4, 1996 September 7, 2011
NCT01399606 Completed Phase 3 Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) May 2011 September 2016
NCT01485770 Completed Phase 2 A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness December 2011 May 2012
NCT01624480 Completed Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy July 2012 December 2015
NCT01681121 Completed Phase 2 A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy September 2012 August 2013
NCT01719315 Completed Neurophysiologic Correlates of Hypersomnia November 2012 June 2018
NCT01789398 Completed Phase 3 Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) September 2012 August 2014
NCT02348593 Completed Phase 3 "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy" May 2015 February 2017
NCT02348632 Completed Phase 3 "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA" May 2015 December 2017
NCT02720744 Completed Phase 3 Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy November 17, 2016 March 25, 2020
NCT02769780 Completed A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy July 8, 2015 August 9, 2021
NCT04940806 Enrolling by invitation The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With Narcolepsy May 1, 2021 June 2025
NCT05113745 Enrolling by invitation Phase 3 A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy October 20, 2021 December 2024
NCT05371483 Enrolling by invitation Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments May 18, 2022 July 2026
NCT05530447 No longer available Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
NCT05870735 Not yet recruiting Discovering Factors in Narcolepsy Patients' Clinical Research Experiences June 2024 June 2026
NCT06383806 Not yet recruiting N/A Decreasing Nightmares in Adults With Narcolepsy July 2024 September 2026
NCT05536011 Recruiting WAKIX® (Pitolisant) Pregnancy Registry August 24, 2021 June 30, 2030
NCT05884112 Recruiting N/A Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation February 22, 2023 June 2025
NCT06179407 Recruiting Phase 1 Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004) January 24, 2024 December 5, 2024
NCT06279247 Recruiting Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy September 1, 2022 September 2024
NCT05321355 Recruiting Mainz Register of Patients With Sleep Disorders February 1, 2022 January 31, 2030
NCT04330963 Recruiting International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study January 6, 2020 June 30, 2026
NCT05615584 Recruiting N/A Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence February 15, 2023 October 30, 2025
NCT06413420 Recruiting SUNOSI® (Solriamfetol) Pregnancy Registry July 31, 2019 September 2029
NCT05773872 Recruiting N/A Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia March 7, 2023 March 2025
NCT05869773 Recruiting Phase 4 A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy June 26, 2023 July 1, 2025
NCT04899947 Recruiting Child and Adolescent Registry for Participants With Narcolepsy October 10, 2020 October 1, 2024
NCT05875974 Recruiting Phase 4 Ph4 PSG Combined JZP258-407 July 27, 2023 November 1, 2024
NCT04419792 Suspended 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy' October 15, 2019 September 30, 2020
NCT01792583 Terminated The Nuvigil and Provigil Pregnancy Registry June 30, 2009 November 30, 2023
NCT00366080 Terminated Phase 2 Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy November 2006 January 2008
NCT05373979 Unknown status Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale April 2, 2019 April 30, 2023
NCT03425214 Unknown status N/A Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder January 19, 2018 June 30, 2019
NCT02799849 Unknown status N/A Metabolism Characteristics in the Children With Narcolepsy December 20, 2013 November 2019
NCT00484757 Unknown status N/A Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition June 2007 August 2009
NCT03376568 Unknown status Investigation of Clinical Feature and Brain Function in Narcoleptic Patients January 28, 2016 December 30, 2019
NCT02077036 Unknown status N/A Narcolepsy - New Potential Treatment
NCT05627388 Withdrawn N/A Feasibility Study of At-Home EEG Monitoring for Hypersomnia February 2023 April 1, 2024
NCT03626727 Withdrawn Early Phase 1 Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia September 2020 September 1, 2020
Disase is a (Disease Ontology)
DOID:535
Cross Reference ID (Disease Ontology)
GARD:7162
Cross Reference ID (Disease Ontology)
ICD10CM:G47.41
Cross Reference ID (Disease Ontology)
ICD9CM:347.0
Cross Reference ID (Disease Ontology)
MESH:D009290
Cross Reference ID (Disease Ontology)
MIM:161400
Cross Reference ID (Disease Ontology)
MIM:605841
Cross Reference ID (Disease Ontology)
MIM:609039
Cross Reference ID (Disease Ontology)
MIM:612417
Cross Reference ID (Disease Ontology)
MIM:612851
Cross Reference ID (Disease Ontology)
MIM:614223
Cross Reference ID (Disease Ontology)
MIM:614250
Cross Reference ID (Disease Ontology)
NCI:C84489
Cross Reference ID (Disease Ontology)
ORDO:2073
Cross Reference ID (Disease Ontology)
SNOMEDCT_US_2023_03_01:155059003
Cross Reference ID (Disease Ontology)
UMLS_CUI:C0027404
Exact Synonym (Disease Ontology)
Narcolepsy, without cataplexy
Exact Synonym (Disease Ontology)
paroxysmal sleep
HPO Human Phenotype ID (Human Phenotype Ontology)
HP:0030050
OMIM Phenotype Series Number (OMIM)
PS161400
MeSH unique ID (MeSH (Medical Subject Headings))
D009290