Search for a trial

AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS

FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy (excessive…

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.

Investigating bedtime procrastination and circadian phase in patients with delayed sleep phase disorder

The current research is set to provide insight into the phenotypic characteristics of DSPD patients in terms of psychological characteristics, occurrence of co-morbidities, and behavioural characteristics such as bedtime routines and lifestyle, and…

Sleep and biorhythm in ICU patients: a pilot study

To investigate the incidence and severity of disturbed biorhythm among ICU patients, and the effect on quality of sleep. We also aim to validate the novel ICU Depth Of Sleep (IDOS) index in detecting depth of sleep over time. Secondarily: we will…

A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERS

FT218 is a new formulation (composition) of the registered drug sodium oxybate. Sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]) is registered under the name Xyrem® for the treatment of narcolepsy. The purpose of…

An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

During the study, an oral solution of JZP-507 produced on a commercial scale will be compared with a JZP-507 oral solution produced on a pilot scale (an oral solution of JZP-507 which is manufactured locally at PRA). The purpose of the study is to…

A comparative, open-label, randomized, 2-stage sequential design, 2 periods, crossover study to demonstrate the bioequivalence of 2 FT218 batches (single dose of 4.5 gram) in healthy volunteers

The purpose of the study is to investigate how quickly and to what extent 2 different production batches of FT218 (batch A and batch B) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, ParallelGroup, Multicenter Study of the Safety and Efficacy of JZP 110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA)

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 37.5, 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with OSA.

A double-blind, randomized study to evaluate plasma prolactin levels in healthy volunteers after single oral doses of lorazepam

Evaluation of the effect of single oral doses of lorazepam on plasma concentration of prolactin

Voluntary motor activity in Restless Legs Syndrome and Periodic Limb Movements in Sleep

The aim of this study is to investigate the differences between RLS and PLMS.

A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects

The key objective of this study is to assess next-day residual effects of MK-4305 (20 and 40 mg) via driving performance after 1 day of dosing and after 8 days of dosing.

Double-blind, placebo- and active-controlled, randomized, single-ascending dose study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-462206 in healthy male subjects

- To evaluate the safety and tolerability of ascending single oral doses of ACT-462206 in healthy male subjects.- To investigate the single oral dose PK and PD of ACT-462206 in healthy male subjects.- To investigate dose proportionality across…

Sleep State Misperception Mispercieved?

We aim to establish whether our judgment of *misperception* is really doing justice to the condition paradoxical insomniacs suffer from. We should keep in mind that our present definition of sleep, based on the standardized polysomnographic scoring…

Confusion of Dreaming with Reality in Narcolepsy

The goals of the present study, therefore, are twofold:a) To estimate the incidence of dream/reality confusions in the narcoleptic population, relative to healthy controlsb) To provide a comprehensive description of the characteristics of these…

Efficacy of timed bright light exposure and physical activity in the treatment of Delayed Sleep Phase Disorder

The main objective is to determine whether a 5-day intervention of daily timed physical exercise improves sleep parameters and is capable of resetting the circadian clock in patients with DSPD. The secondary objectives are to compare the efficacy of…

Double blind, placebo controlled, randomized study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oxathridine
after a single oral administration ranging from 0.5 mg to 100 mg in healthy male subjects (part 1) followed by the assessment of the effect of 3 different oxathridine oral doses on polysomnography in comparison to 50 mg diphenhydramine and placebo in healthy male subjects (part 2).

Primary objective: Study Part 1 : Single Ascending Dose: • To determine the clinical and biological safety and tolerability of oxathridine after an oral increasing single dose administration oxathridine in healthy male subjects. Study Part 2 : Proof…

Sleep apnea and disorders in cognitive and emotional functioning after stroke

Determination of SDB prevalence in patients after strokeDetermination of the relationships between SDB (in particular OSAS) and complants of fatigue and complaints of emotional and cognitive disturbances in patients who experienced a stroke.…

Assessment of next-morning driving performance after middle of the night administration of zolpidem tartrate sublingual tablet 3.5 mg in healthy adult volunteers: single-center, double-blind, randomized, placebo-controlled, four-way crossover study

The aim of the study is to assess the risk of impaired driving in the morning at 3 and 4 hours after a middle-of-the-night dose of zolpidem tartrate sublingual tablet 3.5 mg.

Sodium Oxybate for the Treatment of Vigilance Impairment in Narcolepsy

Core:1. Quantify vigilance using a portable task battery three times daily during 7 days while subjects are outside the hospital 1.1 Comparing narcoleptic patients to controls 1.2 Comparing narcoleptic patients before and after treatment with sodium…

Prospective, randomized, double-blind study, parallel-group, multi-center trial assessing the effects of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy.

Evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy attacks.Evaluate the additive/synergistic effect of the combination of BF2.649 and Modafinil on excessive daytime sleepiness (EDS…