Clinical trials: Narcolepsy
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
Narcolepsy, Excessive Sleepiness
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
- Trial name
- NCT02806908
- Testing
- JZP-110
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week…
- Trial name
- NCT00049803
- Testing
- sodium oxybate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Orphan Medical
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 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
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
Narcolepsy
Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
The goal of the study is to assess the risk of occurrence of narcolepsy following the administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the province of Quebec, Canada, using different case…
- Trial name
- NCT01394614
- Testing
- A/H1N1 vaccine
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
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
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
Narcolepsy
Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.
- Trial name
- NCT05870735
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
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
Narcolepsy Type 1, Narcolepsy Type 2
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness [EDS]).
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- CRYSTAL-1 (NCT06752668)
- Testing
- ORX750
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 248 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
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
Narcolepsy, Cataplexy
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)
This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients…
- Trial name
- HARMONYIII (NCT01399606)
- Testing
- BF2.649
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Bioprojet
Narcolepsy
Metabolism Characteristics in the Children With Narcolepsy
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children.
- Trial name
- Narcolepsy (NCT02799849)
- Testing
- Sleep and metabolism assessment
- Where
- France
- Volunteers
- 24 people
- 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.