Clinical trials: Narcolepsy
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness.
- Trial name
- NCT03772314
- Testing
- Modafinil, Amphetamine-Dextroamphetamine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Emory University
Narcolepsy Type 1
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT1 (NCT07455383)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy
TElemedicine for NARcolepsy
The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.
- Trial name
- TENAR (NCT04316286)
- Testing
- Tele-multidisciplinary care, Standard care
- Where
- Italy
- Volunteers
- 202 people
- Sponsor
- Azienda Usl di Bologna
Narcolepsy
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.
- Trial name
- NCT05015673
- Testing
- SEP363856
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Narcolepsy Type 1 (NT 1)
A Study of TAK-994 in Adults With Narcolepsy
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994.
- Trial name
- NCT04820842
- Testing
- TAK-994
- Where
- 70 sites in United States, Canada and 8 more
- Volunteers
- 26 people
- Sponsor
- Takeda
Healthy Volunteers, Narcolepsy Type 1
Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
The purpose of this study is to determine whether portable devices can provide measurements at home similar to those taken in the clinic, in particular in participant with NT1, and to investigate night-to-night changes in sleep…
- Trial name
- NCT04445129
- Testing
- Portable EEG Device, Portable ECG Device, Accelerometry
- Where
- 13 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Takeda
Narcolepsy, Narcolepsy Type 1
Narcolepsy Nightmare Study
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are: Is imagery rehearsal therapy (IRT) effective for narcolepsy-related…
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Type 2
- Trial name
- NCT05709873
- Testing
- Imagery rehearsal therapy, Targeted dream control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University
Hypersomnia, Primary Hypersomnia
Flumazenil for the Treatment of Primary Hypersomnia
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night).
- Conditions
- Hypersomnia, Primary Hypersomnia, Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
- Trial name
- NCT01183312
- Testing
- Flumazenil
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lynn Marie Trotti
Narcolepsy With Cataplexy, Healthy Controls
Xyrem and Brain Dopamine in Narcolepsy
The overall aim of this investigation is to establish whether an action of Xyrem® on the brain dopamine system in patients with narcolepsy, and in a comparison control group, might explain part of the anti-narcoleptic effect of…
- Trial name
- NCT02637076
- Testing
- Xyrem
- Where
- Canada
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Centre for Addiction and Mental Health
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 Type 1
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- NCT07540897
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1)
A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia
The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia.
- Conditions
- Idiopathic Hypersomnia, Narcolepsy Type 1 (NT 1), Narcolepsy Type 2 (NT2)
- Trial name
- COMPANION (NCT07006233)
- Testing
- Whole Food Ketogenic Diet, Whole Food Diet
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- University of Sydney
Narcolepsy Type 1
Clinical and Neurophysiological Characteristics of Narcolepsy
The study is the first attempt in post-Soviet Russian history to collect and analyze the existing available data of narcolepsy cohort in order to get prove characteristics of narcolepsy in Russia according to known data.
- Trial name
- NCT05375890
- Testing
- no intervention
- Where
- 11 sites in Russia
- Volunteers
- 89 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Narcolepsy
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with…
- Trial name
- HARMONY IV (NCT01789398)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Bioprojet
Narcolepsy, Cataplexy
An Open Label Study of FT218 in Subjects With Narcolepsy
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium…
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder
- Trial name
- RESTORE (NCT04451668)
- Testing
- FT218
- Where
- 29 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Avadel
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Wakefulness Disorder, Narcolepsy
Hypersomnia in the Paediatric Population
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included: Group A: children from the general population with no complaints of sleepiness; Group B…
- Conditions
- Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
- Trial name
- SOMNO-PED (NCT07766343)
- Testing
- Sleepness and wakeness scale, Polysomnography, Actimetry
- Where
- France
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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