Ph4 PSG Combined JZP258-407

Narcolepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875974
• Other study ID #: JZP258-407
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia
• Narcolepsy

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