An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy

NCT04794491 | Completed Phase 4 Results FDA Drug

• 1 other identifier: JZP258-401
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 28

Brief Summary

The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

• Change in Weekly Rate of Cataplexy Attacks

  Mean weekly rate of cataplexy attack = (total number of cataplexy attacks reported during the period/number of days during the period where a diary was completed) x 7.

  Baseline to Week 8

Other Outcomes (8)

• Change in the Nausea Visual Analog Scale (NVAS)

  Baseline to Week 8

• Number of Participants With Patient Global Impression of Change (PGIc) Values

  Week 8

• Change in Epworth Sleepiness Scale (ESS)

  Baseline to Week 8

Study Arms (1)

Open-Label Conversion and Treatment Optimization

EXPERIMENTAL

Conversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.

Drug: JZP-258

Interventions

JZP-258 DRUG

Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose \> 6 g

Also known as: XYWAV

Open-Label Conversion and Treatment Optimization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Participant must be 18 to 80 years of age (inclusive), at the time of signing the informed consent. Type of Participant and Disease Characteristics
• Participants who have a primary diagnosis of Type 1 or Type 2 narcolepsy that meets ICSD-3 criteria or DSM-5 criteria (Ruoff and Rye 2016), and are being currently treated with Xyrem, with or without additional anticataplectics or stimulants.
• Participants who have been taking Xyrem (with or without additional anticataplectics or stimulants eg, TCA, SNRI, SSRI, atomoxetine) in a stable dose and regimen for at least two months prior to screening, with evidence of clinical improvement on their current regimen, per the investigator's judgement. Only Xyrem will be substituted with XYWAV, with dose and regimen of any concomitant anticataplectics or stimulants remaining unchanged throughout the study.
• Sex and Contraceptive/Barrier Requirements
• Participant is male or female
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
• Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 3 OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), preferably with low user dependency, as described in Appendix 3, during the study Intervention period and for at least 7 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (serum) during screening.
• Informed Consent
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Medical Conditions
• Have a diagnosis of narcolepsy, secondary to another medical condition (eg, central nervous system injury or lesion)
• Are currently prescribed a Xyrem regimen exceeding a dose of 9 grams nightly, or any single dose in excess of 6 grams.
• Have been diagnosed with restless leg syndrome (RLS) requiring treatment other than iron supplements
• Exhibit succinic semi-aldehyde dehydrogenase deficiency (SSADH)
• Have uncontrolled hypothyroidism
• Have a history of seizures, excluding early childhood non-pathological febrile seizures
• Have a history of head trauma associated with loss of consciousness in the past 5 years, or if the event occurred more than 5 years prior to screening and the participant experiences sequelae due to the event
• Show evidence of untreated or inadequately treated sleep-disordered breathing including:
• Presence of clinically significant and untreated obstructive or central sleep apnea (as determined by the investigator or documented previously); or one of the following:
• Apnea index (AI) \>10 if on Obstructive Sleep Apnea (OSA) treatment or untreated, or
• Clinically significant hypoventilation, or
• Noncompliance with primary OSA therapy Note: "Non-compliance" is defined as positive airway pressure use of \<4 hours per night on \<70% of nights (\<5 of 7 nights/week) per historical report (with investigator concurrence) of use of an oral appliance on \<70% of nights (≥5 of 7 nights/week), or receipt of an effective surgical intervention for OSA symptoms.
• Experience parasomnias (eg, sleep walking, REM Sleep Behavior Disorder, etc.) considered by the investigator to negatively impact the conduct of the study. Parasomnia events associated with physical injury to the participant (or others) shall be discussed with the sponsor Medical Monitor.
• Meet criteria for current major depression based on clinical interview

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (28)

Wright Clinical Research, LLC

Alabaster, Alabama, 35007, United States

Location

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Pulmonary Associates of the Southeast, PC

Birmingham, Alabama, 35254, United States

Location

Santa Monica Clinical Trials

Los Angeles, California, 90025, United States

Location

Southern California Institute For Respiratory Diseases, Inc./ Tower Sleep Medicine

Los Angeles, California, 90048, United States

Location

Southern California Institute For Respiratory Diseases, Inc.

Los Angeles, California, 90048, United States

Location

Stanford University- Sleep Medicine

Redwood City, California, 94063, United States

Location

SDS Clinical Trials, Inc

Santa Ana, California, 92705, United States

Location

Delta Waves, Inc.

Colorado Springs, Colorado, 80918, United States

Location

Pulmonary Disease Specialists, PA d/b/a PDS Research

Kissimmee, Florida, 34741, United States

Location

Clinical Research of West Florida, Inc

Tampa, Florida, 33606, United States

Location

Florida Pediatric Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Sleep Practitioners LLC

Macon, Georgia, 31210, United States

Location

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

WMed Center for Clinical Research

Kalamazoo, Michigan, 49008, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Clayton Sleep Institute, LLC

St Louis, Missouri, 63123, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Intrepid Research LLC

Cincinnati, Ohio, 45245, United States

Location

Cleveland Clinic, Sleep Disorders Center

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences

North Charleston, South Carolina, 29425, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Macfadden W, Leary EB, Fuller DS, Kirby MT, Roy A. Effectiveness and optimization of low-sodium oxybate in participants with narcolepsy switching from a high-sodium oxybate: data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav study. J Clin Sleep Med. 2024 Sep 1;20(9):1467-1477. doi: 10.5664/jcsm.11182.

  PMID: 38652499 DERIVED

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals

ClinicalTrialDisclosure@jazzpharma.com

215-832-3750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 12, 2021
• Study Start: March 22, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)