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Mapping for Acute Transvenous Phrenc nerve Stimulation Study

Protocol page 17The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins.

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.

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

What keeps the brain alert? - A magnetic resonance study into the neural correlates of vigilance in narcolepsy patients

No studies have yet investigated brain activity in NC patients in relation to alertness and sleep resistance. The aim of the current study is to obtain more insight into the regulatory mechanisms controlling alertness and sleep resistance in…

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…

Validation of the Actiwatch for older people with intellectual disability; a feasibility study

The first objective of this study is to investigate the feasibility of performing home sleep EEG registrations in older people with intellectual disability. The second objective of this study is the determine which sensitivity setting of the Sleep…

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…

The role of hypocretin in food-related motivation and self-control: A fMRI study in narcolepsy patients

To understand the neurocognitive mechanism underlying food-related motivation and control in patients with narcolepsy with cataplexy.

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…

Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm.

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…

PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER TRIAL ASSESSING THE EFFECTS OF BF2.649 IN TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN NARCOLEPSY
(*HARMONY 1*)

· Evaluate the efficacy and safety of BF2.649 administered by escalating doses and followed by 5-week stable doses in narcoleptic patients with excessive daytime sleepiness (EDS) as compared to placebo.· Evaluate the efficacy and safety of BF2.649…