Narcolepsy: Clinical Trials

26 completed. 26 Phase 3.

By phase and status

Phase	Trials	Status
Phase 3	26	Completed 26

Follow Narcolepsy: new trials by email Literature Review of Narcolepsy trials Research Report on Narcolepsy

Trials (filtered) newest first · largest first

All 26 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) AXS-12 (reboxetine), Placebo - Narcolepsy, Cataplexy	Phase 3	Completed	Axsome Therapeutics, Inc.	68	2021-10-20	2025-11-13
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy AXS-12 (reboxetine), Placebo - Narcolepsy, Cataplexy	Phase 3	Completed	Axsome Therapeutics, Inc.	90	2021-09-15	2026-05-28
An Open Label Study of FT218 in Subjects With Narcolepsy FT218 - Narcolepsy, Cataplexy	Phase 3	Completed	Avadel	184	2020-06-12	2025-10-02
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy JZP-258, Placebo - Narcolepsy With Cataplexy	Phase 3	Completed	Jazz Pharmaceuticals	201	2017-03-14	2020-11-12
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy FT218, Placebo - Excessive Daytime Sleepiness, Cataplexy	Phase 3	Completed	Avadel	212	2016-11-17	2022-03-22
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period pitolisant, Placebo - Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy	Phase 3	Completed	Bioprojet	110	2016-06-06	2025-06-26
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy" JZP-110, Placebo oral tablet - Narcolepsy	Phase 3	Completed	Jazz Pharmaceuticals	239	2015-05-01	2019-07-23
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA" JZP-110 - Narcolepsy, Obstructive Sleep Apnea	Phase 3	Completed	Jazz Pharmaceuticals	645	2015-05-01	2019-06-25
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy Xyrem - Narcolepsy With Cataplexy	Phase 3	Completed	Jazz Pharmaceuticals	106	2014-10-01	2019-04-30
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) Pitolisant, Placebo - Narcolepsy With Cataplexy, Excessive Daytime Sleepiness	Phase 3	Completed	Bioprojet	103	2013-04-01	2016-08-31
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) BF2.649 - Narcolepsy	Phase 3	Completed	Bioprojet	51	2012-09-01	2015-11-18
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) BF2.649 - Narcolepsy, Cataplexy	Phase 3	Completed	Bioprojet	102	2011-05-01	2017-01-31
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. BF2.649, Vigil, palcebo - Treatment of Excessive Daytime Sleepiness in Narcolepsy	Phase 3	Completed	Bioprojet	180	2010-11-01	2017-01-31
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy BF2.649, BF2.649 add on Modafinil - Narcolepsy, Cataplexy	Phase 3	Completed	Bioprojet	14	2009-10-01	2013-02-11
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy BF2.649, Modafinil, Placebo - Narcolepsy, Excessive Daytime Sleepiness	Phase 3	Completed	Bioprojet	110	2009-05-01	2012-06-11
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Armodafinil - Excessive Daytime Sleepiness, Narcolepsy	Phase 3	Completed	Cephalon	247	2005-10-01	2013-07-19
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness Modafinil - Narcolepsy	Phase 3	Completed	Cephalon	92	2005-01-01	2012-05-31
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Modafinil - Narcolepsy, Sleep Apnea, Obstructive	Phase 3	Completed	Cephalon	280	2004-10-01	2014-05-09
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Modafinil - Narcolepsy	Phase 3	Completed	Cephalon	140	2004-10-01	2012-08-24
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Xyrem (sodium oxybate) oral solution - Narcolepsy	Phase 3	Completed	Jazz Pharmaceuticals	59	2004-10-01	2013-11-25

Showing 20 of 26. Sign in to see all of them.

Narrower conditions

Disorders of Excessive Somnolence (16)  ·  Cataplexy (14)  ·  Sleep Apnea, Obstructive (5)  ·  Sleep Wake Disorders (4)  ·  Chronobiology Disorders (1)  ·  Hemorrhage (1)  ·  Ischemia (1)  ·  Ischemic Attack, Transient (1)  ·  Parasomnias (1)  ·  Sleep Apnea Syndromes (1)  ·  Sleep Disorders, Circadian Rhythm (1)  ·  Stroke (1)

Broader conditions

Dyssomnias (26)  ·  Mental Disorders (26)  ·  Nervous System Diseases (26)  ·  Sleep Disorders, Intrinsic (26)  ·  Sleep Wake Disorders (22)  ·  Disorders of Excessive Somnolence (10)  ·  Apnea (5)  ·  Pathological Conditions, Signs and Symptoms (5)  ·  Respiration Disorders (5)  ·  Respiratory Tract Diseases (5)  ·  Neurologic Manifestations (4)  ·  Signs and Symptoms (4)  ·  Sleep Apnea Syndromes (4)  ·  Brain Diseases (1)  ·  Brain Ischemia (1)

Interventions

Modafinil (10)  ·  pitolisant (7)  ·  Sodium Oxybate (5)  ·  Reboxetine (2)  ·  solriamfetol (2)  ·  FANG vaccine (1)  ·  Solutions (1)  ·  disufenton sodium (1)

Sponsors

Bioprojet (7)  ·  Cephalon (7)  ·  Jazz Pharmaceuticals (6)  ·  Avadel (2)  ·  Axsome Therapeutics, Inc. (2)  ·  AstraZeneca (1)  ·  Orphan Medical (1)

Countries

United States (16)  ·  Canada (12)  ·  France (12)  ·  Germany (6)  ·  Switzerland (5)  ·  Finland (4)  ·  Netherlands (4)  ·  Russia (4)  ·  Australia (3)  ·  Czechia (3)  ·  Belgium (2)  ·  Hungary (2)  ·  Italy (2)  ·  Spain (2)  ·  Argentina (1)

Top investigators

Claudio Bassetti (2)  ·  Evelyne De Paillette, Dr (1)  ·  Giuseppe Plazzi, MD (1)  ·  Harry N Cook, MBA, RPh (1)  ·  Kati Gutierrez, PharmD (1)  ·  William Houghton, MD (1)  ·  Yanping Zheng, MD (1)

Results publications

PMID 32356515, PMID 34822113, PMID 34935103, PMID 16895262, PMID 17687131, PMID 21206549, PMID 24107292, PMID 27778193, PMID 27807903, PMID 28129985, PMID 29221779, PMID 30169321, PMID 31691827, PMID 31926465, PMID 32588401, PMID 33179591, PMID 33184650, PMID 33226332, PMID 34283019, PMID 34358324, PMID 34606437, PMID 34920345, PMID 35380374, PMID 35635687, PMID 35689598, PMID 36084494, PMID 36931805, PMID 36947322, PMID 37942930, PMID 39153911, PMID 39263597, PMID 39321628, PMID 40111738, PMID 40111739, PMID 40851446, PMID 42163487

NIH funding

2008 (2), 2016 (1)