Clinical trials: Disorders of Excessive Somnolence
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 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
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06767683
- Testing
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 786 people
- Sponsor
- Alkermes, Inc.
Hepatic Encephalopathy
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and…
- Trial name
- NCT02163837
- Testing
- rifaximine
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome
Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome
The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS).
- Trial name
- NCT07077278
- Testing
- Low sodium oxybate (LXB)
- Volunteers
- 25 people
- Sponsor
- Stanford University
Major Depressive Disorder, Primary Hypersomnia
Neurophysiologic Correlates of Hypersomnia
The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction…
- Conditions
- Major Depressive Disorder, Primary Hypersomnia, Bipolar Disorder, Narcolepsy
- Trial name
- NCT01719315
- Testing
- Acoustical slow wave induction
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.
- Trial name
- NCT00366080
- Testing
- GSK189254
- Where
- 14 sites in Austria, Finland and 4 more
- Volunteers
- 69 people
- Sponsor
- GlaxoSmithKline
Narcolepsy With Cataplexy, Narcolepsy
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.
- Conditions
- Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy
- Trial name
- NCT05055024
- Testing
- Mazindol
- Where
- 22 sites in United States
- Volunteers
- 52 people
- Sponsor
- NLS Pharmaceutics
Narcolepsy, Obstructive Sleep Apnea
Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life.
- Trial name
- PN-PROS (NCT05373979)
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- Boston Children's Hospital
Sleepiness, Fatigue
Integral Physiological Adaptations to Carbohydrate Periodization
The purpose of this study is to examine the effect of long-term carbohydrate periodization protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance, body composition, gut microbiome, and miRNA in…
- Conditions
- Sleepiness, Fatigue, Feeding Patterns, Daytime Sleepiness, Excessive
- Trial name
- IPACP (NCT05464342)
- Testing
- Evening LGI Carbohydrate Consumption Group, Evening HGI Carbohydrate Consumption, Evening NO-CHO Carbohydrate Consumption
- Where
- 2 sites in Cyprus, Greece
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Thessaly
Major Depression, Mental Health
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depressive Disorder when added to…
- Trial name
- NCT00208715
- Testing
- Provigil
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- Emory University
Haemodialysis-induced Symptom
Sleep Quality and Related Factors in Hemodialysis Patients
Sleep quality is an important predictor of healthy status,quality of life and life span. Sleeping problems affect 50%~80% in hemodialysis patients.
- Trial name
- NCT01327560
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- Taipei Medical University WanFang Hospital
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
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
Post-Acute COVID-19 Syndrome, ME/CFS
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related…
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA)
- Trial name
- NCT04806620
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Brain Inflammation Collaborative
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Parkinson's Disease
Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease
This is an open-label cross-over randomized control study comparing the effect of modafinil and methylphenidate in patients with Parkinson's disease with excessive daytime sleepiness.
- Trial name
- NCT00393562
- Testing
- modafinil, methylphenidate
- Where
- United States
- Sponsor
- US Department of Veterans Affairs
Idiopathic Hypersomnia
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
- Trial name
- SOLR-IH (NCT06590662)
- Testing
- Solriamfetol
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Montpellier