Jazz Pharmaceuticals
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
The trial has 3 treatment periods: open label titration and optimization period (OL-TOP), stable dose period (SDP) and the double-blind randomized withdrawal period (DBRWP). Participants will be evaluated by their disease cohort (Narcolepsy and IH). Once eligibility to participate in the trial is confirmed, eligible participants will begin OL-TOP. Participants with narcolepsy and IH will be assigned to receive either a once-nightly expanded dosing of Xywav or a twice-nightly expanded dosing of Xywav. Assignment is dependent on participant's standard oxybate treatment and the treating investiga…
Inclusion Criteria: 1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2) 2. Participants with a primary diagnosis of NT1 must have a history of at least 14 cataplexy attacks in a typical 2-week period, based on participant history at the time of diagnosis and prior to initiating treatment. 3. Participants with a primary diagnosis of IH must have an average total nightly sleep time of at least 7 hours, based on participant history at the time of diagnosis and prior to initiating treatment. 4. If not currently treated with oxybate, has clinically significant symptoms of…
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth
Placebo solution taken by mouth
Arctuva estimate
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