Ph4 PSG Combined JZP258-407

January 25, 2024 updated by: Jazz Pharmaceuticals

A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy

This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This prospective, multicenter, single-arm, open-label interventional study will assess the safety and efficacy of JZP258 on sleepiness, polysomnography measurements (eg, sleep stage transitions, sleep patterns, and sleep quality), daytime and nighttime symptoms, pharmacokinetics (in narcolepsy), and patient-reported outcomes that include subjective sleep quality and quality of life in patients with IH or narcolepsy.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Recruiting
        • Sleep Disorders Center of Alabama
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Santa Monica Clinical Trials
      • Santa Ana, California, United States, 92705
        • Recruiting
        • SDS Clinical Trials, Inc.
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • BioSerenity
      • Miami, Florida, United States, 33176
        • Recruiting
        • PharmaDev Clinical Research Institute, LLC
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Florida Hospital for Children
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • NeuroTrials Research, Inc.
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saltzer Medical Group
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
        • Recruiting
        • Clinical Neurophysiology Services, P.C.
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Advanced Respiratory and Sleep Medicine, PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Intrepid Research
      • Dublin, Ohio, United States, 43017
        • Recruiting
        • Ohio Sleep Medicine and Neuroscience Institute
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Abington Neurological Associates, LTD
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Bogan Sleep Consultants, LLC
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Sleep Therapy & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Is 18 to 75 years of age (inclusive) at the time of signing the informed consent form (ICF)
  • Has a primary diagnosis of IH meeting International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria or narcolepsy (Type 1 or Type 2) meeting ICSD-3 or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
  • If not currently taking oxybate medication, has clinically significant symptoms of Excessive daytime sleepiness (EDS) with an ESS score > 10 at Screening Visit 1. If currently taking oxybate medication, has an ESS score > 10 at the Baseline Visit 2 polysomnography (after washout period).
  • If currently treated with anticataplectics and/or alerting agents, has been taking the same dosage for at least 1 month prior to Screening Visit 1 and has no current plans to adjust the dosage during the study period.

Key Exclusion Criteria:

  • Shows evidence of a previous untreated or inadequately treated sleep disorder considered by the investigator to negatively impact the conduct of the study, including sleep-disordered breathing, parasomnias, circadian rhythm sleep disorders, or restless legs syndrome determined by a previous sleep-laboratory diagnosis or interview utilizing modules of the Diagnostic Interview for Sleep Patterns and Disorders.
  • Shows evidence of untreated or inadequately treated sleep-disordered breathing during Baseline Visit 2 polysomnography defined as an Apnea/Hypopnea Index (AHI) > 10, using the US Centers for Medicare and Medicaid Services rules (CMS.gov).
  • Has a history or presence of any unstable or clinically significant medical condition (chronic pain condition that may impact sleep), behavioral or psychiatric disorder (including active suicidal ideation or current or past [within 1 year] major depressive episode), or history or presence of another neurologic disorder or surgical history that might affect the participant's safety and/or interfere with the conduct of the study, in the opinion of the investigator.
  • Has recently taken (ie, within 1 month prior to screening), is taking, or plans to take any of the following:

    • A substance or medication contraindicated with XYWAV use, ie. specifically alcohol and sedative hypnotics
    • A medication with a known drug-drug interaction with XYWAV
    • A medication that may have similar EEG effects to XYWAV
    • Medications known to have clinically significant CNS sedative effects
    • Other medications, natural health products, or substances from which the participant experiences clinically significant sedation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JZP258
Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.
Initiate dosage per XYWAV label and titrate to variable dosage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Impression of Change (PGI-C) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Time Frame: End of Treatment (approximately 10-36 weeks)
End of Treatment (approximately 10-36 weeks)
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)
Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)
Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-21 weeks)
Baseline up to End of Treatment (approximately 10-21 weeks)
Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)
Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)
Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) In a Subset of Participants With Narcolepsy Treated With XYWAV
Time Frame: PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose
PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose
Pharmacokinetic Parameter Area Under the Concentration-Time Curve From time 0 to Infinity (AUC0-inf) In a Subset of Participants With Narcolepsy Treated With XYWAV
Time Frame: PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose
PK: Predose, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour post-first dose and post-second dose, 6 hour post-first dose, 8 hour post-first dose
Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV
Time Frame: Baseline up to End of Treatment (approximately 10-36 weeks)
Baseline up to End of Treatment (approximately 10-36 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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