8 results
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…
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…
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.-…
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…
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.
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,…
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,…
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…