Phase 2 N=30 Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Parkinson Disease
Primary: Sleep and Fatigue — 15.6; 9.0; 10.9; 6.6 units on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=33 A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Narcolepsy
Primary: Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With…
Phase 2 N=95 A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Excessive Daytime Sleepiness · Narcolepsy
Primary: Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase — 6.30; 5.81; 1.29; 1.10 minutes — p=0.418
N/A N=144 Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
Sleep Apnea, Obstructive
Primary: Subjective Sleepiness — 11.8; 10.2; 9.9 units on a scale
Phase 2 N=93 A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Narcolepsy
Primary: Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last…
Phase 4 N=13 SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Chronic Fatigue Syndrome
Primary: EEG Slow Wave Activity During Sleep — 0.00002653; 0.00002257 uV^2/Hz
Phase 3 N=263 Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
Obstructive Sleep Apnea · Sleep Hypopnea
Primary: Maintenance of Wakefulness Test (MWT) — 2.3; -1.3 Minutes — p=0.0003
Phase 2 N=77 Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Parkinson Disease
Primary: Safety Adverse Events — 0; 0; 0; 0 participants
Phase 3 N=395 Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
Obstructive Sleep Apnea · Hypopnea
Primary: Maintenance of Wakefulness Test (MWT) — 2.2; 1.7; -1.7 Minutes — p=0.0001
Phase 3 N=254 Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
Excessive Sleepiness · Shift Work Sleep Disorder
Primary: Multiple Sleep Latency Test (MSLT) — 3.1; 0.4 Minutes — p=<0.0001
Phase 2 N=24 Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Narcolepsy · Excessive Sleepiness
Primary: Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax) — 20.46; 19.08 centimeter (cm) — p=0.0022
Phase 2 N=30 Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
Myotonic Dystrophy 1 · Excessive Daytime Sleepiness
Primary: Change in Excessive Daytime Sleepiness (EDS) Based on Change in Daytime Sleepiness Scale (DSS) Score — -3.8; -1.8; 0.0 score on a scale
Phase 2 N=10 Flumazenil for the Treatment of Primary Hypersomnia
Hypersomnia · Primary Hypersomnia · Idiopathic Hypersomnia
Primary: Change in Psychomotor Vigilance Task (PVT) Median Reaction Time — -9.86; -4.46 msec — p=0.77
Phase 2 N=244 BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Excessive Daytime Sleepiness · Parkinson Disease
Primary: Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. — -4.34; -4.64; -3.46; -4.73 units on a scale — p=0.668
Phase 3 N=174 "Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Obstructive Sleep Apnea
Primary: Change in the Maintenance of Wakefulness Test (MWT) — -0.96; -12.11 minutes
Phase 1 N=56 Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
Apnea, Sleep
Primary: Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo — 18.66; 18.62; 20.71; 10.50 Minutes
Phase 4 N=19 Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Sleep Disorder, Shift-Work
Primary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05
Phase 2 N=34 Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
Obstructive Sleep Apnea · Excessive Sleepiness
Primary: Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax) — 19.92; 18.83 centimeter (cm) — p=0.0062
N/A N=24 Effects of Daytime Eszopiclone Administration in Shift Workers
Shift-Work Sleep Disorder
Primary: Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests — 11.0; 14.75 minutes
Phase 3 N=474 "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Obstructive Sleep Apnea
Primary: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 — 4.74; 9.08; 10.96; 12.99 minutes
Phase 3 N=743 Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Excessive Daytime Sleepiness · Narcolepsy · Obstructive Sleep Apnea/Hypopnea Syndrome
Primary: Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) — 667 Participants
Phase 3 N=23 Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Sleep Apnea, Obstructive · Diabetes Mellitus, Type 2
Primary: Physical Activity, Steps Walked — 5892; 6071; 6284; 6684 steps walked
Phase 2 N=66 A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Excessive Sleepiness · Parkinson Disease
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation — 1; 2; 0; 0 Participants
Phase 3 N=236 "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Narcolepsy
Primary: Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 — 2.12; 4.74; 9.77; 12.27 minutes
Phase 4 N=383 Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
Excessive Sleepiness
Primary: Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at…
Phase 2 N=40 Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
Insomnia
Primary: Change in Daytime Insomnia Symptoms Scale (DISS) — 65.96; 70.34; 69.22; 72.32 units on a scale
Phase 4 N=29 Lemborexant Shift Work Treatment Study
Shift-Work Related Sleep Disturbance
Primary: Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary — 362.7; 365.3 Minutes per day — p=0.884
Phase 3 N=196 Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Narcolepsy
Primary: Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks — 2.6; 1.3; -1.9; 1.9 Minutes — p=0.0024
N/A N=15 Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Primary: Feasibility of Recruitment and Retention — 8; 6; 8; 6 participants
Phase 2 N=23 Clarithromycin for the Treatment of Hypersomnia
Hypersomnia · Idiopathic Hypersomnia · Narcolepsy
Primary: Psychomotor Vigilance Task (PVT) Reaction Time — 279.1; 311.6; 333.8 Msec — p=0.47