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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05875974
Other study ID # JZP258-407
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 27, 2023
Est. completion date November 1, 2024

Study information

Verified date April 2024
Source Jazz Pharmaceuticals
Contact Clinical Trial Disclosure & Transparency
Phone 215-832-3750
Email ClinicalTrialDisclosure@JazzPharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 186
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
JZP258 (XYWAV)
Initiate dosage per XYWAV label and titrate to variable dosage.

Locations

Country Name City State
Canada Heritage Medical Research Clinic, University of Calgary Calgary Alberta
Canada AMNDX Inc Markham Ontario
Canada Johda Tishon Inc Toronto Ontario
Canada Toronto Sleep Institute Toronto Ontario
United States Abington Neurological Associates, LTD Abington Pennsylvania
United States BioSerenity Altamonte Springs Florida
United States NeuroTrials Research, Inc. Atlanta Georgia
United States FutureSearch Trials of Neurology Austin Texas
United States Sleep Disorders Center of Alabama Birmingham Alabama
United States St. Lukes Hospital Medical Center Chesterfield Missouri
United States CTI Clinical Research Center Cincinnati Ohio
United States Intrepid Research Cincinnati Ohio
United States Cleveland Clinic Main Campus - Clinical Research Unit Cleveland Ohio
United States Bogan Sleep Consultants, LLC Columbia South Carolina
United States Ohio Sleep Medicine and Neuroscience Institute Dublin Ohio
United States Clinical Research of Gastonia Gastonia North Carolina
United States Comprehensive Sleep Medicine Associates Houston Texas
United States Advanced Respiratory and Sleep Medicine, PLLC Huntersville North Carolina
United States Long Beach Research Institute Lakewood California
United States Santa Monica Clinical Trials Los Angeles California
United States PharmaDev Clinical Research Institute, LLC Miami Florida
United States Saltzer Medical Group Nampa Idaho
United States Stanford School of Medicine Redwood City California
United States Sleep Therapy & Research Center San Antonio Texas
United States SDS Clinical Trials, Inc. Santa Ana California
United States Perseverance Research Center, LLC Scottsdale Arizona
United States Clinical Neurophysiology Services, P.C. Sterling Heights Michigan
United States Florida Hospital for Children Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epworth Sleepiness Scale (ESS) Total Score in Participants With IH and Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Idiopathic Hypersomnia Severity Scale (IHSS) Total Score in Participants With IH Treated With XYWAV Baseline up to End of Treatment (approximately 10-21 weeks)
Secondary Number of Stage Shifts of Sleep in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Duration of Sleep Stages in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Number of Nocturnal Awakenings and Nocturnal Arousals in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Percentage of Sleep Stages in Participants With Narcolepsy Treated With XYWAV Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Patient Global Impression of Change (PGI-C) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue) End of Treatment (approximately 10-36 weeks)
Secondary Level of Rested or Refreshed Upon Awakening in Participants With IH and Narcolepsy Treated With XYWAV (Sleep Diary) Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Patient Global Impression of Severity (PGI-S) Score in Participants With IH and Narcolepsy Treated With XYWAV (Overall, Sleep Inertia, and Fatigue) Baseline up to End of Treatment (approximately 10-36 weeks)
Secondary Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) In a Subset of Participants With Narcolepsy Treated With XYWAV 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
Secondary 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 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
See also
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