This study is looking at how well and how safely Xywav works for adults with narcolepsy or idiopathic hypersomnia (IH), a condition causing extreme daytime sleepiness. Researchers are testing different ways to take Xywav, a liquid medicine containing calcium, magnesium, potassium, and sodium oxybates. You might be able to join if you are 18 to 75 years old and have a diagnosis of narcolepsy (Type 1 or Type 2) or IH. If you're not currently taking oxybate, you'll need to have significant daytime sleepiness. The main goal is to see how Xywav affects your sleepiness, measured by a score called the Epworth Sleepiness Scale (ESS), over about 14 to 16 weeks. The current status of this study is unclear.

Study design

This interventional study plans to enroll 108 participants. It involves two treatment periods: a titration and optimization period where you'll receive Xywav, followed by a randomized withdrawal period where you might continue Xywav or receive a placebo (an inactive substance).

What's involved

You would participate in a titration and optimization period for up to 14 weeks to find your stable Xywav dose. After that, you would enter a randomized withdrawal period for an additional 2 weeks.

Compensation

Not stated in the trial record.

Follow-up

Your sleepiness will be measured at the end of the stable dose period (up to Week 14) and up to the end of the randomized withdrawal period (up to Week 16).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.