Phase 2 N=190 A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Narcolepsy
Primary: Epworth Sleepiness Scale — -5.1; -5.6; -3.3 score on a scale — p=0.024
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=212 Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Excessive Daytime Sleepiness · Cataplexy · Narcolepsy
Primary: Maintenance of Wakefulness Test (MWT) — 10.8; 4.7 minutes — p=<0.001
Phase 3 N=201 A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Narcolepsy With Cataplexy
Primary: Change in Weekly Number of Cataplexy Attacks — 0.00; 2.35 attacks
Phase 2 N=112 A Study of TAK-861 in Participants With Narcolepsy Type 1
Narcolepsy Type 1
Primary: Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 — -1.16; 12.49; 23.50; 25.42 minutes — p==0.001
Phase 3 N=110 Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
Narcolepsy With Cataplexy · Narcolepsy Without Cataplexy
Primary: To Evaluate the Efficacy of Pitolisant in Reducing Residual Excessive Daytime Sleepiness (EDS), Ullanlinna Narcolepsy Scale Score. — -6.29; -2.60 score on a scale
Phase 2 N=21 Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Narcolepsy · Cataplexy Narcolepsy · Excessive Sleepiness
Primary: Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks — 13.0; -0.28 weekly cataplexy attacks — p=<0.001
Phase 3 N=106 A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Narcolepsy With Cataplexy
Primary: Change in Weekly Number of Cataplexy Attacks — 0.27; 12.71 number of attacks
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=210 A Study to Collect Information of People With Narcolepsy in Spain
Narcolepsy
Primary: Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit — 5.10; 7.55; 94.90; 92.45 percentage of participants…
Phase 2 N=44 Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Idiopathic Hypersomnia · Narcolepsy Without Cataplexy
Primary: Change in Epworth Sleepiness Scale (ESS) Score — 5.0; 4.4 score on a scale
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=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
Phase 2 N=71 A Study of TAK-861 in Participants With Narcolepsy Type 2
Narcolepsy Type 2
Primary: Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 — 2.14; 1.90; 4.54 minutes — p==0.989
N/A N=60 Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Narcolepsy · Narcolepsy Without Cataplexy · Narcolepsy With Cataplexy
Primary: Number of Participants Who Attended ≥ 80% of Sessions — 15; 13; 15 Participants
Phase 3 N=328 Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Narcolepsy · Sleep Apnea, Obstructive · Sleep Apnea Syndromes
Primary: Safety and Tolerability as Measured by Number of Participants With Adverse Events — 323 Participants
Phase 4 N=17 Xyrem and Brain Dopamine in Narcolepsy
Narcolepsy With Cataplexy · Healthy Controls
Primary: [C-11]Raclopride BPND at 1 Hour Post Xyrem — 2.94; 3.01; 3.80; 3.70 BPND (Binding Potential) — p=0.31
Phase 3 N=247 Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Excessive Daytime Sleepiness · Narcolepsy · Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Primary: Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings — 241 Participants
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 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 1 N=25 Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Narcolepsy With Cataplexy
Primary: The Insulin-like Growth Factor 1 (IGF-1) Measured in Fasting Conditions at Baseline (Visit 2) — 207.4 ng/mL
Phase 2 N=48 Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Narcolepsy
Primary: Epworth Sleepiness Scale (ESS) — 14.68; 15.34; 15.34 score on a scale
Phase 3 N=231 Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Narcolepsy
Primary: Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) — -2.72; 0.58; -0.53; 2.68 Minutes — p=<0.001
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 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=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 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 3 N=59 Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Narcolepsy
Primary: Adverse Experiences — 54 participants
Phase 3 N=28 Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Nocturia · Daytime Sleepiness
Primary: Change From Baseline in Epworth Sleepiness Scale [ESS] — 9.03; 9.73 units on a scale
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 4 N=60 Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Obstructive Sleep Apnea Syndrome
Primary: The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI). — 22.33; 18.18; 21.10; 22.71 Apnea + Hypopnea episodes per hour — p=0.009