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NarcolepsyPhase 4NCT04794491

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

A Phase 4 study testing JZP-258 in people with Narcolepsy, run by Jazz Pharmaceuticals at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Narcolepsy
What is being tested?
JZP-258
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
28 sitesUnited States
Study dates
22 Mar 2021to 15 Nov 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • Have any clinically relevant medical, behavioral, or psychiatric disorder (other than narcolepsy) that is associated with excessive sleepiness
  • Have a history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  • Have a history or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological 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
  • Display relevant suicidality as indicated by Columbia Suicide Severity Rating Scale (C-SSRS) evaluation at screening
  • Display moderate to severe depression as indicated by the Participant Health Questionnaire - 9 (PHQ-9) at screening
  • Are a female participant who is pregnant or breastfeeding
  • Prior/Concomitant Therapy
  • Have undergone treatment with any prohibited central nervous system (CNS) agents, including but not limited to benzodiazepines, non-benzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, eg, diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment. Discontinuation for the purpose of study enrollment is permitted only if considered safe by the investigator and approved by the Medical Monitors.
  • Prior/Concurrent Clinical Study Experience
  • Received any other investigational drug within 30 days or five half-lives (whichever is longer) prior to screening, or plan to use an investigational drug (other than the study intervention) during the study.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Wright Clinical Research, LLC

    Alabaster, Alabama, 35007

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213

  • Pulmonary Associates of the Southeast, PC

    Birmingham, Alabama, 35254

  • The Center for Sleep & Wake Disorders

    Chevy Chase, Maryland, 20815

  • Intrepid Research LLC

    Cincinnati, Ohio, 45245

  • Cleveland Clinic, Sleep Disorders Center

    Cleveland, Ohio, 44195

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80918

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • WMed Center for Clinical Research

    Kalamazoo, Michigan, 49008

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

    Kissimmee, Florida, 34741

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025

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

    Los Angeles, California, 90048

  • Southern California Institute For Respiratory Diseases, Inc.

    Los Angeles, California, 90048

  • Sleep Practitioners LLC

    Macon, Georgia, 31210

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

    North Charleston, South Carolina, 29425

  • Stanford University- Sleep Medicine

    Redwood City, California, 94063

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229

  • SDS Clinical Trials, Inc

    Santa Ana, California, 92705

  • Clayton Sleep Institute, LLC

    St Louis, Missouri, 63123

  • Clinical Research Institute

    Stockbridge, Georgia, 30281

  • Clinical Research of West Florida, Inc

    Tampa, Florida, 33606

  • Florida Pediatric Research Institute, LLC

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of Narcolepsy

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
Being tested
JZP-258
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP-258Drug

    Also called XYWAV

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

Study groups in NCT04794491
Study groupRoleWhat they receive
Open-Label Conversion and Treatment OptimizationExperimentalConversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.
Receives: Drug: JZP-258

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2021
  2. Study start22 Mar 2021
  3. Primary completion15 Nov 2022
  4. Study completion15 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04794491
Sponsor's protocol ID
JZP258-401
Status last verified
Jan 2024
First submitted
25 Feb 2021
Last updated
9 Jan 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38652499

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing JZP-258 in people with Narcolepsy, run by Jazz Pharmaceuticals at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weekly Rate of Cataplexy Attacks (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04794491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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