Clinical trials: Excessive Sleepiness
Partial Epilepsy
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications.
- Trial name
- NCT01190098
- Testing
- Lacosamide
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
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
Narcolepsy
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.
- Trial name
- NCT00132873
- Testing
- Xyrem (sodium oxybate) oral solution
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy.
- Trial name
- SUVN-G3031 (NCT04072380)
- Testing
- SUVN-G3031
- Where
- 41 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Suven Life Sciences Limited
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
Insomnia, Blindness
Melatonin for Circadian Sleep Disorders in the Blind
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1).
- Conditions
- Insomnia, Blindness, Daytime Sleepiness
- Trial name
- NCT00911053
- Testing
- Melatonin, Regular Sleep Schedule, Light
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Oregon Health and Science University
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
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
- NCT01485770
- Testing
- ADX-N05
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Jazz Pharmaceuticals
Excessive Sleepiness
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.
- Trial name
- NCT00758498
- Testing
- armodafinil
- Where
- 4 sites in United States
- Volunteers
- 427 people, healthy volunteers welcome
- Sponsor
- Cephalon
Narcolepsy Without Cataplexy, Idiopathic Hypersomnia
Clarithromycin Mechanisms in Hypersomnia Syndromes
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia.
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Trial name
- NCT04026958
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Emory University
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
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
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Seasonal Allergic Rhinitis
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will…
- Trial name
- NCT00997620
- Testing
- Fluticasone furoate Nasal Spray 110 mcg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Western Sky Medical Research
Excessive Sleepiness, Shift-work Disorder
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).
- Trial name
- NCT04788953
- Testing
- Solriamfetol Oral Tablet
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Charles A. Czeisler, PhD, MD
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 Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate.
- Trial name
- XYLO (NCT05869773)
- Testing
- JZP258
- Where
- 43 sites in United States, Belgium and 3 more
- Volunteers
- 155 people
- Sponsor
- Jazz Pharmaceuticals
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.
Idiopathic Hypersomnia
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).
- Trial name
- NCT04091438
- Testing
- TAK-925
- Where
- 22 sites in United States, Japan
- Volunteers
- 28 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
- Trial name
- NCT04794491
- Testing
- JZP-258
- Where
- 28 sites in United States
- Volunteers
- 62 people
- Sponsor
- Jazz Pharmaceuticals