Clinical trials: Disorders of Excessive Somnolence
Idiopathic Hypersomnia
Study of SDX in Patients With Idiopathic Hypersomnia (IH)
This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).
- Trial name
- NCT05668754
- Testing
- Serdexmethylphenidate
- Where
- 41 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zevra Therapeutics
COPD
Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist, are approved for use in the management of COPD.
- Trial name
- NCT00731770
- Testing
- Advair 250, Advair 250 - matched
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Milton S. Hershey Medical Center
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
Nocturia, Daytime Sleepiness
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
- Trial name
- NCT02151253
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Excessive Daytime Sleepiness, Cataplexy
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
- Conditions
- Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
- Trial name
- NCT02720744
- Testing
- FT218
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 212 people
- Sponsor
- Avadel
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
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1).
- Trial name
- NCT06179407
- Testing
- MK-6552
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
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 Collect Information of People With Narcolepsy in Spain
This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly.
- Trial name
- SOMNUS (NCT04667338)
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- Takeda
Renal Disease, Sleep Disorders
Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation
Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective disorder, jet lag and shift work.
- Trial name
- SleepTx-1 (NCT01256983)
- Testing
- Bright Light Therapy, Wait-list intervention
- Volunteers
- 30 people
- Sponsor
- University of Basel
Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.
- Trial name
- NCT02611687
- Testing
- pitolisant
- Where
- 11 sites in Finland, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Bioprojet
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
Narcolepsy With Cataplexy
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.
- Trial name
- NCT00345800
- Testing
- Sodium Oxybate (Xyrem)
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- UCB Pharma SA
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.
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
Diabetic Retinopathy, Macular Degeneration
Advancing Understanding of Transportation Options
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers.
- Conditions
- Diabetic Retinopathy, Macular Degeneration, Glaucoma, Retinitis Pigmentosa
- Trial name
- AUTO (NCT04141891)
- Testing
- Driving Decision Aid, Older Drivers Website
- Where
- 3 sites in United States
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Narcolepsy With Cataplexy
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
- Trial name
- NCT03030599
- Testing
- JZP-258
- Where
- 25 sites in United States, Belgium and 4 more
- Volunteers
- 201 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Parkinson Disease
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.
- Trial name
- NCT03624920
- Testing
- THN102 Dosage A, THN102 Dosage B, THN102 Dosage C
- Where
- 34 sites in United States, Czechia and 3 more
- Volunteers
- 77 people
- Sponsor
- Theranexus
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