Clinical trials: Daytime Sleepiness, Excessive
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, 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 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
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major…
- Trial name
- CLARITY (NCT07484217)
- Testing
- Solriamfetol 150 MG
- Where
- 40 sites in United States
- Volunteers
- 508 people
- Sponsor
- Axsome Therapeutics, Inc.
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
Obstructive Sleep Apnea
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA) from a finger. This can be measured using the Somnocheck micro system.
- Trial name
- NCT01690429
- Testing
- Somnocheck micro
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV
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.
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.
Idiopathic Hypersomnia
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
- Trial name
- NCT07500090
- Testing
- HBS-301 tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 248 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy, Cataplexy
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- SYMPHONY (NCT05059223)
- Testing
- AXS-12 (reboxetine)
- Where
- 50 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Axsome Therapeutics, Inc.
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
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.
Parkinson Disease, Excessive Daytime Somnolence
Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study
Following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (MSLT) and polysomnogram (PSG) assessments to confirm eligibility for…
- Trial name
- NCT05056194
- Testing
- Valiloxybate
- Sponsor
- XWPharma
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.
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.
Sleep, Relaxation
Sleep and Morning Wellbeing Study
The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Trial name
- NCT07311434
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Athletic Greens International
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.
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
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.