Clinical trials: Disorders of Excessive Somnolence
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
Apnea, Sleep Disorders
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive…
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Trial name
- VESPER-OSA 2 (NCT07881757)
- Testing
- Berobenatide
- Where
- 2 sites in United States
- Volunteers
- 258 people
- Sponsor
- Pfizer
Idiopathic Hypersomnia
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
- Trial name
- Vibrance-3 (NCT06843590)
- Testing
- ALKS 2680
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 126 people
- Sponsor
- Alkermes, Inc.
Narcolepsy Type 1
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- NCT07540897
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Sleep, Sleep Quality
Nextsense Brain-sensing Buds Study
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress.
- Conditions
- Sleep, Sleep Quality, Sleepiness, Daytime, Technology
- Trial name
- NCT06602960
- Testing
- Accurate Sleep Data Feedback, Inflated Sleep Data Feedback, Deflated Sleep Data Feedback
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NextSense, Inc.
Narcolepsy
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
- Trial name
- NCT03267303
- Testing
- TS-091 5mg, TS-091 10mg
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 53 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Narcolepsy Type 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Trial name
- Vibrance-2 (NCT06555783)
- Testing
- ALKS 2680
- Where
- 47 sites in United States, Australia and 6 more
- Volunteers
- 93 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Obstructive Sleep Apnea
The Nuvigil and Provigil Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- Trial name
- NCT01792583
- Testing
- Modafinil/armodafinil
- Where
- United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Cephalon, Inc.
Narcolepsy
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1).
- Trial name
- NCT06179407
- Testing
- MK-6552
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy
This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval.
- Trial name
- NCT03433131
- Testing
- Pitolisant
- Where
- 71 sites in United States
- Sponsor
- Harmony Biosciences Management, Inc.
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.
- Trial name
- NCT04886518
- Testing
- Pitolisant Oral Tablet
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Harmony Biosciences Management, Inc.
Excessive Sleepiness
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
- Trial name
- NCT00758498
- Testing
- armodafinil
- Where
- 4 sites in United States
- Volunteers
- 427 people, healthy volunteers welcome
- Sponsor
- Cephalon
Sleep Disorders, Obstructive Sleep Apnea
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea…
- Conditions
- Sleep Disorders, Obstructive Sleep Apnea, Major Depressive Disorder, Dysthymic Disorder
- Trial name
- NCT00518986
- Testing
- armodafinil
- Where
- 62 sites in United States
- Volunteers
- 249 people
- Sponsor
- Cephalon
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the…
- Trial name
- NCT04803786
- Testing
- Transition from Xyrem to Xywav
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
Excessive Daytime Sleepiness, Narcolepsy
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated…
- Trial name
- NCT01006122
- Testing
- PF-03654746
- Where
- 21 sites in United States
- Volunteers
- 95 people
- Sponsor
- Pfizer
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
Excessive Daytime Sleepiness, Parkinson Disease
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with…
- Trial name
- CASPAR (NCT03194217)
- Testing
- BEN-2001
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BenevolentAI Bio
Chronic Insomnia, Sleep Deprivation
Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders.
- Conditions
- Chronic Insomnia, Sleep Deprivation, REM Behavior Disorder, REM Sleep Behavior Disorder
- Trial name
- PSHW (NCT06644573)
- Testing
- PROSOMNIA Sleep Therapy™ (PSTx), Anesthesia-Induced Sleep Therapy, Diprivan (propofol), Astra-Zeneca
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nyree Penn