Clinical trials: Disorders of Excessive Somnolence
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
- 26 sites in United States
- Volunteers
- 222 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy Type 2
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT2 (NCT07502443)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 176 people
- Sponsor
- Alkermes, Inc.
Narcolepsy
A Study of HBS-201 (Pitolisant Delayed-release)
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
- Trial name
- NCT07051252
- Testing
- HBS-201
- Where
- 15 sites in United States
- Volunteers
- 46 people
- Sponsor
- Harmony Biosciences Management, Inc.
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
Idiopathic Hypersomnia
Study of SDX in Patients With Idiopathic Hypersomnia (IH)
This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).
- Trial name
- NCT05668754
- Testing
- Serdexmethylphenidate
- Where
- 41 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zevra Therapeutics
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 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
Excessive Daytime Sleepiness
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Trial name
- NCT07082829
- Testing
- ORX142 Tablets
- Where
- 3 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment.
- Trial name
- NCT07540364
- Testing
- Samelisant
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Suven Life Sciences Limited
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
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 obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Cerebral Stroke, Stroke, Acute
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.
- Conditions
- Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
- Trial name
- NCT00061022
- Testing
- NXY-059
- Where
- 256 sites in United States, Argentina and 28 more
- Volunteers
- 3,200 people
- Sponsor
- AstraZeneca
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
Idiopathic Hypersomnia
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension.
- Trial name
- NCT06525077
- Testing
- FT218
- Where
- 7 sites in United States
- Volunteers
- 157 people
- Sponsor
- Avadel
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
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy.
- Trial name
- NCT00066170
- Testing
- Xyrem, Modafinil at established dose
- Where
- 40 sites in United States, France and 2 more
- Volunteers
- 231 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well…
- Trial name
- NCT05530447
- Testing
- Samelisant
- Sponsor
- Suven Life Sciences Limited
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 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
Prader-Willi Syndrome
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, 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