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NCT05875974 | Recruiting | Idiopathic Hypersomnia


Ph4 PSG Combined JZP258-407
Sponsor:

Jazz Pharmaceuticals

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.

Condition or disease

Idiopathic Hypersomnia

Narcolepsy

Intervention/treatment

JZP258 (XYWAV)

Phase

Phase 4

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
Estimated Enrollment : 186 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2023
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024
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.

Drug: JZP258 (XYWAV)

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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

Ph4 PSG Combined JZP258-407

Location Details


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Ph4 PSG Combined JZP258-407

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Alabama

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States, 35213

Recruiting

United States, California

Long Beach Research Institute

Lakewood, California, United States, 90805

Recruiting

United States, California

Santa Monica Clinical Trials

Los Angeles, California, United States, 90025

Recruiting

United States, California

SDS Clinical Trials, Inc.

Santa Ana, California, United States, 92705

Recruiting

United States, Florida

BioSerenity

Altamonte Springs, Florida, United States, 32701

Recruiting

United States, Florida

PharmaDev Clinical Research Institute, LLC

Miami, Florida, United States, 33176

Recruiting

United States, Florida

Florida Hospital for Children

Winter Park, Florida, United States, 32789

Recruiting

United States, Georgia

NeuroTrials Research, Inc.

Atlanta, Georgia, United States, 30328

Recruiting

United States, Idaho

Saltzer Medical Group

Nampa, Idaho, United States, 83686

Recruiting

United States, Michigan

Clinical Neurophysiology Services, P.C.

Sterling Heights, Michigan, United States, 48314

Recruiting

United States, Missouri

St. Lukes Hospital Medical Center

Chesterfield, Missouri, United States, 63017

Recruiting

United States, North Carolina

Clinical Research of Gastonia

Gastonia, North Carolina, United States, 28054

Recruiting

United States, North Carolina

Advanced Respiratory and Sleep Medicine, PLLC

Huntersville, North Carolina, United States, 28078

Recruiting

United States, Ohio

CTI Clinical Research Center

Cincinnati, Ohio, United States, 45212

Recruiting

United States, Ohio

Intrepid Research

Cincinnati, Ohio, United States, 45245

Recruiting

United States, Ohio

Ohio Sleep Medicine and Neuroscience Institute

Dublin, Ohio, United States, 43017

Recruiting

United States, Pennsylvania

Abington Neurological Associates, LTD

Abington, Pennsylvania, United States, 19001

Recruiting

United States, South Carolina

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States, 29201

Recruiting

United States, Texas

FutureSearch Trials of Neurology

Austin, Texas, United States, 78731

Recruiting

United States, Texas

Comprehensive Sleep Medicine Associates

Houston, Texas, United States, 77030

Recruiting

United States, Texas

Sleep Therapy & Research Center

San Antonio, Texas, United States, 78229

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