Clinical trials: Excessive Daytime Somnolence
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.
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.
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.
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.
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.
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, 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, Excessive Daytime Sleepiness
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2…
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- Trial name
- NCT04923594
- Testing
- mazindol extended release
- Where
- 22 sites in United States
- Volunteers
- 67 people
- Sponsor
- NLS Pharmaceutics
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
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 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
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, 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.
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.
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
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
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 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.
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
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