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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 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.

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…

Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients

Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?

A Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Circadin® To Alleviate Sleep Disturbances in Children with Neurodevelopment Disabilities.

To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)

Primary:- To assess the effect of TAK-861 on EDS as measured by sleep latency from the MWT.Secondary:- To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. - To evaluate the safety and tolerability of…

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.-…

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Primary: - To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).Please refer to the Study protocol for detailed description on the secondary Objective of…

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.

DOUBLE BLIND, MULTICENTRE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE SAFETY AND EFFICACY OF PITOLISANT IN CHILDREN FROM 6 TO LESS THAN 18 YEARS WITH NARCOLEPSY WITH/WITHOUT CATAPLEXY, FOLLOWED BY A PROLONGED OPEN-LABEL PERIOD

- To evaluate the efficacy of pitolisant ( 5, 10, 20,40mg/d in the Double Blind Period and 5, 10, 15, 20, 30, 40mg/d in the Open Label Period) in reducing residual Excessive Daytime Sleepiness (EDS) and the number of cataplectic episodes (for…

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 Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Primary ObjectiveThe primary objective of the study is:• To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating EDS in both NT1 and NT2 subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT)…

A Long-Term, Safety and Maintenance of Efficacy Study of JZP110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea

To evaluate the safety and tolerability of JZP-110 administered once daily for up to 52 weeks in doses of 75, 150, and 300 mg

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal,;Multicenter Study of the Efficacy and Safety of Xyrem with an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy

Primary objectives are:1) To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy2) To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with…

A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy

Primary objective:To evaluate the efficacy of JZP-258 in the treatment of cataplexy in subjects with narcolepsyKey Secondary objective:To evaluate the efficacy of JZP-258 in the treatment of excessive daytime sleepiness (EDS) in…