Clinical trials: Narcolepsy
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
Narcolepsy
Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults.
- Trial name
- NARCOWORK (NCT03173378)
- Testing
- Questionnaires
- Where
- France
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Healthy Participants and Patients With Narcolepsy
Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1…
- Trial name
- NCT03332784
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Takeda
Narcolepsy
Body Weight Regulation in Patients With Narcolepsy
This study will measure energy expenditure (the rate at which the body burns calories), physical activity and caloric intake in people with narcolepsy to learn more about how the risk of becoming overweight or diabetic may be…
- Trial name
- NCT00283894
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Narcolepsy Type 1, Idiopathic Hypersomnia
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia
Links between sleep and food intake are manyfold. In healthy individuals, sleep deprivation promotes obesity by stimulating food intake of high glycemic index (GI) foods. Conversely, high GI foods induce sleepiness.
- Trial name
- NARCOFOOD (NCT06484348)
- Testing
- Monitoring of eating behaviors, Monitoring of sleep/wake rhythm, Measure of nocturnal sleep parameters
- Where
- 2 sites in France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Narcolepsy, Idiopathic Hypersomnia
International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study
Swiss Primary Hypersomnolence and Narcolepsy Cohort Study (SPHYNCS) is a cohort study on disease presentation and long-term course with an exploratory approach to detect biomarkers.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Hypersomnolence Disorder
- Trial name
- iSPHYNCS (NCT04330963)
- Where
- Switzerland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Narcolepsy
Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations
Narcolepsy type 1 (NT1) is a neurological disorder characterized by excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations while awake.
- Trial name
- NarcoGen (NCT06786377)
- Testing
- saliva sampling
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Narcolepsy
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)
Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies).
- Trial name
- NCT03765892
- Testing
- Questionnaire (Adult), Questionnaire (Children)
- Where
- 18 sites in France
- Volunteers
- 1,605 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Narcolepsy Type 1 (NT1)
A Phase 1, First-in-human Study of VX-433
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion…
- Trial name
- NCT07584434
- Testing
- VX-433, Midazolam, Bupropion
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
ADHD, Narcolepsy
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine…
- Trial name
- NCT04232644
- Testing
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Narcolepsy, Cataplexy
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients.
- Trial name
- NC-TCSP-IRMf (NCT03425214)
- Testing
- fMRI, Videopolysomnography, NC (narcolepsy-cataplexy)
- Where
- France
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand
Narcolepsy, Hypersomnia
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks.
- Trial name
- AUTOSOP (NCT00916253)
- Testing
- Modafinil
- Where
- 2 sites in France
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Sleep Apnea, Temporo-central Epilepsy
Sleep and Memory in Children
Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning is necessary for knowledge consolidation.
- Conditions
- Sleep Apnea, Temporo-central Epilepsy, Narcolepsy, High Intellectual Potential
- Trial name
- EnSOM (NCT02785328)
- Testing
- memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment), memory evaluation at V1 and V2 (without treatment)
- Where
- France
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Narcolepsy
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo…
- Trial name
- NARKOREX (NCT00484757)
- Testing
- Orexine A
- Where
- Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zentrum für Integrative Psychiatrie
Hypersomnia in Children
Amylase and Hypersomnia
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia.
- Trial name
- Amylase (NCT01926405)
- Testing
- saliva collection
- Where
- France
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
ADHD, Narcolepsy
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant…
- Trial name
- SEAL (NCT04647903)
- Testing
- ADAIR 10 mg IR tablets, d-amphetamine sulfate
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
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
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 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, 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