A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT07625280
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Xywav — DRUG
    0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth
  • Placebo — OTHER
    Placebo solution taken by mouth

Study Details

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).

Key Dates

First listed
Jun 4, 2026
Start date
Jul 9, 2026
Status verified
Aug 2026
Primary completion
Dec 23, 2027
Completion
Jan 6, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: IH Cohort twice-nightly expanded Xywav dose group
    Participants with IH will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks.
  • Placebo Comparator: IH Cohort twice-nightly expanded Xywav followed by placebo group
    Participants with IH will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks.
  • Active Comparator: Narcolepsy Cohort once-nightly expanded Xywav dose group
    Participants with narcolepsy will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks.
  • Placebo Comparator: Narcolepsy Cohort once-nightly expanded Xywav followed by placebo group
    Participants with narcolepsy will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks.
  • Active Comparator: Narcolepsy Cohort twice-nightly expanded Xywav dose group
    Participants with narcolepsy will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks.
  • Placebo Comparator: Narcolepsy Cohort twice-nightly expanded Xywav followed by placebo group
    Participants with narcolepsy will receive an expanded twice-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks.
  • Active Comparator: IH Cohort once-nightly expanded Xywav dose group
    Participants with IH will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will continue taking their stable dose of Xywav for 2 additional weeks.
  • Placebo Comparator: IH Cohort once-nightly expanded Xywav followed by placebo group
    Participants with IH will receive an expanded once-nightly dosing of Xywav for up to 14 weeks until they reach a stable dose. Once stable dose is achieved, participants will take placebo for 2 additional weeks.

Primary Outcome Measure

Change in Epworth Sleepiness Scale (ESS) scores [ Time Frame: End of Stable Dose Period (up to Week 14), up to end of Double-Blind Randomized-Withdrawal Period (up to Week 16) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Santa Monica Clinical TrialsLos AngelesCalifornia90025-
Intrepid ResearchCincinnatiOhio45245-
Ohio Sleep Medicine and Neuroscience InstituteDublinOhio43017-

Find similar trials in Los Angeles, CA

By research site
Santa Monica Clinical Trials· Los Angeles, CAIntrepid Research· Cincinnati, OHOhio Sleep Medicine and Neuroscience Institute· Dublin, OH

Related Studies