Clinical trials: Narcolepsy and Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Trial name
- NCT07598708
- Testing
- cleminorexton
- Where
- 23 sites in United States
- Volunteers
- 222 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Excessive Daytime Sleepiness, Narcolepsy
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Trial name
- NCT00228553
- Testing
- Armodafinil 100 to 250 mg/day
- Where
- 100 sites in United States, Australia and 5 more
- Volunteers
- 743 people
- Sponsor
- Cephalon
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy Type 1
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
- Trial name
- NCT05816382
- Testing
- TAK-861
- Where
- 52 sites in United States, Australia and 10 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Narcolepsy Type 1, Hypersomnia
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.
- Conditions
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- Trial name
- NCT06531876
- Testing
- Dreem 3S recording
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Beacon Biosignals
Narcolepsy, Sleep Apnea, Obstructive
Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness…
- Conditions
- Narcolepsy, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Shift-Work Sleep Disorder
- Trial name
- NCT00078312
- Testing
- CEP-10953 (Armodafinil)
- Where
- 50 sites in United States, Russia
- Volunteers
- 328 people
- Sponsor
- Cephalon
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep…
- Trial name
- NCT00078377
- Testing
- Armodafinil
- Volunteers
- 196 people
- Sponsor
- Cephalon
Narcolepsy
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or obstructive sleep apnea/hypopnea…
- Trial name
- NCT00214968
- Testing
- Modafinil
- Volunteers
- 92 people
- Sponsor
- Cephalon
Narcolepsy Type 1, Narcolepsy Type 2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- CRYSTAL-1 (NCT06752668)
- Testing
- ORX750
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 248 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy, Cataplexy Narcolepsy
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy.
- Conditions
- Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness
- Trial name
- CONCERT (NCT03881852)
- Testing
- AXS-12 (Reboxetine)
- Where
- 14 sites in United States
- Volunteers
- 21 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06767683
- Testing
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 786 people
- Sponsor
- Alkermes, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Idiopathic Hypersomnia, Narcolepsy Type 1
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS).
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
- Trial name
- NCT07646678
- Testing
- TAK-360
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Narcolepsy
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
- Trial name
- NCT01624480
- Testing
- Armodafinil
- Where
- 24 sites in United States, Finland
- Volunteers
- 40 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).
- Trial name
- NCT02512588
- Testing
- BTD-001
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- Balance Therapeutics
Narcolepsy
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
- Trial name
- NCT02348593
- Testing
- JZP-110
- Where
- 60 sites in United States, Canada and 4 more
- Volunteers
- 239 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.