Clinical trials: Disorders of Excessive Somnolence
EDS, Cataplexy
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
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 treating excessive daytime sleepiness (EDS), cataplexy…
- Conditions
- EDS, Cataplexy, Fatigue, Narcolepsy
- Trial name
- NCT07675135
- Testing
- HBS-301
- Where
- 53 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Harmony Biosciences Management, Inc.
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Narcolepsy Type 1 (NT1)
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in…
- Trial name
- NCT06462404
- Testing
- E2086, Active Comparator
- Where
- 14 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Excessive Sleepiness
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have…
- Trial name
- NCT00711516
- Testing
- Armodafinil
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cephalon
Narcolepsy
Observational Study of LUMRYZ in Narcolepsy
This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ.
- Trial name
- REFRESH (NCT06792708)
- Testing
- LUMRYZ
- Where
- 12 sites in United States
- Volunteers
- 71 people
- Sponsor
- Avadel
Narcolepsy
A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy…
- Trial name
- NCT02769780
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Jazz Pharmaceuticals
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
Obstructive Sleep Apnea, Sleep Hypopnea
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep…
- Trial name
- NCT00079677
- Testing
- Armodafinil 150 mg/day
- Volunteers
- 263 people
- Sponsor
- Cephalon
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498 compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.
- Trial name
- NCT00424931
- Testing
- JNJ-17216498, Modafinil
- Where
- 16 sites in United States
- Volunteers
- 16 people
- Sponsor
- Alza Corporation, DE, USA
Traumatic Brain Injury
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury…
- Trial name
- NCT00983437
- Testing
- Armodafinil
- Where
- 61 sites in United States
- Volunteers
- 49 people
- Sponsor
- Cephalon, Inc.
Narcolepsy With Cataplexy
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
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Sleepiness, Shift Work Sleep Disorder
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder…
- Trial name
- NCT00080288
- Testing
- Armodafinil 150 mg/day
- Volunteers
- 254 people
- Sponsor
- Cephalon
Idiopathic Hypersomnia, Narcolepsy Type 1
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS).
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
- Trial name
- NCT07646678
- Testing
- TAK-360
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- Takeda
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
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 participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Narcolepsy
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime.
- Trial name
- NCT06961266
- Testing
- JZP441
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Daytime Sleepiness, Narcolepsy
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Trial name
- NCT00228566
- Testing
- Armodafinil
- Where
- 43 sites in United States
- Volunteers
- 247 people
- Sponsor
- Cephalon
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
Major Depressive Disorder, Excessive Sleepiness
Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
- Trial name
- NCT04618263
- Testing
- GATE-101
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Syndeio Biosciences, Inc
Obstructive Sleep Apnea, Hypopnea
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea…
- Trial name
- NCT00078325
- Testing
- Armodafinil 250 mg/day, Armodafinil 150 mg/day
- Volunteers
- 395 people
- Sponsor
- Cephalon