A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Efficacy and Safety of Expanded Dosing Regimens for Xywav in Adult Participants With Narcolepsy or Idiopathic Hypersomnia
Jazz Pharmaceuticals
Summary
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).
Description
The trial has 2 treatment periods: titration and optimization period and the randomized withdrawal period. Once eligibility to participate in the trial is confirmed, eligible participants will begin the titration and optimization treatment period where they will be assigned to either cohort 1 or cohort 2. Participants assigned to Cohort 1 will receive once-nightly dosing of Xywav and participants assigned to Cohort 2 will receive twice-nightly dosing of Xywav. Assignment is dependent on participant's standard oxybate treatment and the treating investigator's decision. During the titration and…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Has a primary diagnosis of IH or narcolepsy Type 1 or Type 2 (NT1 or NT2) 2. If not currently treated with oxybate, has clinically significant symptoms of excessive daytime sleepiness (EDS) with an Epworth Sleepiness Scale (ESS) score \> 11 at screening. 3. If currently treated with oxybate, must have documented improvement of EDS with oxybate treatment per the investigator's clinical judgement. 4. If currently treated with oxybate, has been taking the same stable dosing regimen at a total nightly dosage of 3 g to 9 g (inclusive) for at least 2 months at screening. 5. I…
Interventions
- DrugXywav
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth
- OtherPlacebo
Placebo solution taken by mouth
Location
- Intrepid ResearchCincinnati, Ohio