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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 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…

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 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.

An open-label, randomized crossover pilot study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of Oxybate formulations in healthy subjects.

During the study, the 4 KEY-507 oral solutions (KEY-507-A, KEY-507-G, KEY-507-C, and KEY 507-D) will be investigated and compared to Xyrem. The purpose of the study is to investigate how quickly and to what extent KEY-507 oral solutions are absorbed…

Electrical contrastimulation on the calf for Restless Legs

To assess the efficacy of LEX0 on the calf for Restless Legs (RLS)

An open-label, single-dose study to assess the absolute oral bioavailability and pharmacokinetics of JNJ-42847922 (seltorexant) administered as oral tablet and an intravenous microdose of 14C-seltorexant in healthy participants

In this study we will investigate how safe the new compound seltorexant is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent seltorexant is absorbed, transported, and eliminated…

Efficacy and safety of hydralazine in combination with valproate to treat hypocretin deficiency in recent onset narcolepsy: a pilot study

Primary objective:To assess whether hydralazine in combination with valproate is effective in treating the symptoms of narcolepsy.Secondary objectives:- To assess the safety of treating NT1 patients with hydralazine in combination with valproate.-…

Effectiveness of ketogenic diet on excessive daytime sleepiness in adults with narcolepsy type 1: a proof of concept study

This study comprises a first proof of concept. The primary aim is to investigate the effect of a ketogenic diet on EDS and sustained attention in adult NT1 patients. Secondary aims are to investigate if a ketogenic diet improves weight reduction,…

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

This study has been transitioned to CTIS with ID 2023-508462-15-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of TAK-861.

Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System

This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.

A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the
Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects with
Narcolepsy

PRIMARY OBJECTIVE To characterize the pharmacokinetics (PK) of single doses of solriamfetolin pediatric subjects with narcolepsy.SECONDARY OBJECTIVE To assess the safety and tolerability of single doses of solriamfetol inpediatric subjects with…

A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Narcolepsy

Primary objective:- To evaluate the effect of JZP-110 on driving performanceSecondary objectives:- To evaluate the safety and tolerability of JZP-110- To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving,…

A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Obstructive Sleep Apnea

Primary objective:- To evaluate the effect of JZP-110 on driving performanceSecondary objectives:- To evaluate the safety and tolerability of JZP-110- To explore SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) modeling using driving,…

A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Bedtime Dosing of JZP-324 (Extended Release Oxybate) for Oral Suspension in Healthy Subjects

The purpose of this study is to investigate how quickly and to what extend JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics). It will also be investigated how safe the new compound JZP-324 is and how well it is…

Predicting the success of mandibular repositioning appliance therapy in obstructive sleep apnea

the primary objective of our study is to define a set of patient characteristics that can predict the effectiveness of an MRA in treating symptomatic OSA. The aim of our study is to develop a prediction model to calculate the success rate in an…

An open-label, sequential study to assess the drug-drug interaction of divalproex sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6-G evening dose in healthy male volunteers.

FT218 is a new formulation of the drug sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]), a registered drug under the tradename Xyrem® for the treatment of narcolepsy. FT218 has been administered to humans before.…

An open label, randomized, 4 treatments, 4 periods, 4 sequence crossover study to assess the pharmacokinetics of four 6 g single-doses of once-nightly sodium oxybate (FT218) formulations with varying release rates in healthy volunteers

The purpose of this study is to investigate how quickly and to what extent 4 different formulations of FT218 are absorbed, distributed, metabolized and eliminated from the body.It will also be investigated how safe FT218 is and how well it is…

An open label, sequential study to assess the drug-drug interaction of Divalproex Sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6 g dose in healthy volunteeers

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 this…

An exploratory, open-label, randomized, 2 treatments, 2 periods, 2 sequences crossover study to assess the pharmacokinetics of two FT218 batches (single dose administered at the dose of 6g) in healthy volunteers

FT218 is a new formulation of the drug sodium oxybate (also known as the sodium salt of gamma-hydroxybutyric acid [GHB]), a registered drug under the tradename Xyrem® for the treatment of narcolepsy. FT218 has been administered to humans before.The…