CHORDS - JZP080-301
Research type
Research Study
Full title
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension
IRAS ID
257557
Contact name
Renata Riha
Contact email
Sponsor organisation
Jazz Pharmaceuticals
Eudract number
2018-001311-79
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 14 days
Research summary
Idiopathic hypersomnia (IH) is a rare sleep disorder with an unknown cause. Patients with the condition have excessive daytime sleepiness despite getting enough sleep at night. Patients may have long sleep time (greater than 11 hours of sleep across a 24-hour day) and have trouble waking up on their own in the morning. They often complain of feeling groggy and “drunkenness” upon awaking. Naps are long and do not help patients feel less sleepy during the day.
The main aim of this study is to find out whether the study drug (JZP-258) is safe and works in treating patients with IH (a sleep disorder in which a person is excessively sleepy during the day and has great difficulty being awakened from sleep).
This is a 2-part study - the main study will last approximately 20 weeks and all participants will receive the study drug (JZP-258). Participants will then either continue with the study drug JZP-258 or switch to a placebo for two weeks to see which works better. Upon completion, there is an optional 24-week, Open-Label Extension Period study where participants will receive the study drug JZP-258 (no placebo) and continue to be monitored.
The study will enroll subjects who are diagnosed with IH. Subjects who are currently treated with or without Xyrem or stimulants / alerting agents at study entry will be eligible to enroll.
Approximately 140 people are expected to take part in the study to have a minimum of 112 patients take part in the final phase of the study. Approximately 80 sites in multiple countries will participate.
The study will take place over approximately 24 months. Individual participation will last up to approximately 38 to 42 weeks.
Participants will undergo a range of blood and chemistry tests throughout the study, be provided with sleep and dosing diaries, and complete questionnaires
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0017
Date of REC Opinion
19 Mar 2019
REC opinion
Further Information Favourable Opinion