Clinical trials: Disorders of Excessive Somnolence
Major Depressive Disorder (MDD)
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
- Trial name
- NCT07901179
- Testing
- ALKS 7290 Dose
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Sleep Apnea, Obstructive, Hypopnea Syndrome
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous…
- Conditions
- Sleep Apnea, Obstructive, Hypopnea Syndrome, Excessive Daytime Sleepiness
- Trial name
- NCT00620659
- Testing
- Comparator: MK0249, Comparator: modafinil
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy Type 1, Narcolepsy With Cataplexy
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness.
- Trial name
- AMAZE (NCT05914194)
- Testing
- NLS-2
- Volunteers
- 48 people
- Sponsor
- NLS Pharmaceutics
Narcolepsy
A Study to Collect Information of People With Narcolepsy in Spain
This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly.
- Trial name
- SOMNUS (NCT04667338)
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- Takeda
Healthy, Narcolepsy
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
- Trial name
- NCT06619665
- Testing
- MK-6552, Modafinil
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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.
Obstructive Sleep Apnea
Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime…
- Trial name
- NCT04091425
- Testing
- TAK-925
- Where
- 18 sites in United States
- Volunteers
- 25 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Narcolepsy Type 1
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning.
- Trial name
- NCT07633301
- Testing
- TAK-360
- Where
- 18 sites in United States, Australia and 5 more
- Volunteers
- 92 people
- Sponsor
- Takeda
Narcolepsy
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.
This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.
- Trial name
- NCT05015673
- Testing
- SEP363856
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Trial name
- NCT01681121
- Testing
- ADX-N05
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Jazz Pharmaceuticals
ADHD, Narcolepsy
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine…
- Trial name
- NCT04232644
- Testing
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Sleep Apnea, Hypersomnia
Patient Outcomes in Unattended and In- Lab Polysomnography
This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and…
- Trial name
- NCT05230394
- Testing
- Attended Polysomnography in the Lab, Unattended Polysomnography in the Home
- Where
- Canada
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Cerebra Medical
Narcolepsy Type 1
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
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
- Brilliance NT1 (NCT07455383)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Sleep Apnea, Obstructive, Excessive Daytime Sleepiness
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center…
- Trial name
- NCT06103825
- Testing
- Solriamfetol
- Where
- 26 sites in China
- Volunteers
- 204 people
- Sponsor
- Ignis Therapeutics (Suzhou) Limited
Narcolepsy
Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.
- Trial name
- NCT05870735
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
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.