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A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

Primary Purpose

Idiopathic Hypersomnia, Narcolepsy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
JZP258 (XYWAV)
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypersomnia focused on measuring Idiopathic Hypersomnia, Narcolepsy, Excessive daytime sleepiness, Polysomnography, JZP258, XYWAV, Oxybate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 study entry. If currently taking oxybate medication, has an ESS score > 10 at the Baseline polysomnography Visit (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. Has a history or presence of any unstable or clinically significant medical condition, 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. Is being treated with or has planned treatment with any central nervous system sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, medications containing valproic acid or its sodium salt (eg, Depakene® and Depakote®), other sedating antiseizure medications, melatonin, muscle relaxants, general anesthetics, or any other medication from which the participant experiences sedation.

Sites / Locations

  • Sleep Disorders Center of AlabamaRecruiting
  • Santa Monica Clinical TrialsRecruiting
  • Florida Hospital for ChildrenRecruiting
  • Clinical Neurophysiology Services, P.C.Recruiting
  • Intrepid ResearchRecruiting
  • Ohio Sleep Medicine and Neuroscience InstituteRecruiting
  • Bogan Sleep Consultants, LLCRecruiting
  • Sleep Therapy & Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JZP258

Arm Description

Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.

Outcomes

Primary Outcome Measures

Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV

Secondary Outcome Measures

Patient Global Impression of Change (PGI-C) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary)
Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue)
Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV
Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV
Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Number of Arousals and Awakenings in Participants With Narcolepsy Treated With XYWAV
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) In a Subset of Participants With Narcolepsy Treated With XYWAV
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

Full Information

First Posted
May 16, 2023
Last Updated
September 29, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05875974
Brief Title
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia, Narcolepsy
Keywords
Idiopathic Hypersomnia, Narcolepsy, Excessive daytime sleepiness, Polysomnography, JZP258, XYWAV, Oxybate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JZP258
Arm Type
Experimental
Arm Description
Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.
Intervention Type
Drug
Intervention Name(s)
JZP258 (XYWAV)
Intervention Description
Initiate dosage per XYWAV label and titrate to variable dosage.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time Frame
Baseline up to End of Treatment (approximately 10-36 weeks)
Title
Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV
Time Frame
Baseline up to End of Treatment (approximately 10-36 weeks)
Title
Number of Arousals and Awakenings in Participants With Narcolepsy Treated With XYWAV
Time Frame
Baseline up to End of Treatment (approximately 10-36 weeks)
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 study entry. If currently taking oxybate medication, has an ESS score > 10 at the Baseline polysomnography Visit (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. Has a history or presence of any unstable or clinically significant medical condition, 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. Is being treated with or has planned treatment with any central nervous system sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, medications containing valproic acid or its sodium salt (eg, Depakene® and Depakote®), other sedating antiseizure medications, melatonin, muscle relaxants, general anesthetics, or any other medication from which the participant experiences sedation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Manager
Email
JZP258_406_407_InfoRequest@JazzPharma.com
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Monica Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Hospital for Children
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neurophysiology Services, P.C.
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Individual Site Status
Recruiting
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Sleep Medicine and Neuroscience Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Individual Site Status
Recruiting
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

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