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 Cincinnati, Ohio.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT07625280
Phase
PHASE3
Status
Not Yet Recruiting

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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

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 23, 2027
Completion
Jan 6, 2028

Study Design

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

Arms

  • Active Comparator: Once-nightly stable dose Xywav group
    Participants assigned to cohort 1 will receive 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: Once-nightly placebo group
    Participants assigned to cohort 1 will receive 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: Twice nightly stable dose Xywav group
    Participants assigned to cohort 2 will receive 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: Twice nightly placebo group
    Participants assigned to cohort 2 will receive 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIP
Intrepid ResearchCincinnatiOhio45245

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By research site
Intrepid Research· Cincinnati, OH

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