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Trial record 2 of 2 for:    jazz | Recruiting Studies | NARCOLEPSY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04794491
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: JZP-258 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Experimental: Open-Label Conversion and Treatment Optimization
Conversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.
Drug: JZP-258
Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose > 6 g
Other Name: XYWAV




Primary Outcome Measures :
  1. Number of Participants Converted from Xyrem to XYWAV [ Time Frame: Baseline to Week 8 ]

Secondary Outcome Measures :
  1. Change in Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline to Week 8 ]
    Changes in ESS scores between the Baseline period and ET or E/D, as applicable

  2. Number of Participants with Participant Global Impression of Change (PGIc) Values [ Time Frame: Week 8 ]
    PGIc values will be measured at the ET or E/D, as applicable. The number of participants with each response will be summarized.

  3. Time to Achieve Optimized Dose and Regimen [ Time Frame: Baseline to Week 8 ]
    Defined as the time from the first dose and regimen to the optimized dose and regimen of XYWAV, where the optimized dose and regimen indicates the final dose and regimen that remains unchanged throughout the remainder of the Intervention period.

  4. Number of Changes from the First Dose and Regimen to Optimized Dose and Regimen [ Time Frame: Baseline to Week 8 ]
  5. Number of Participants Dosing Fasted Versus Dosing Without Consideration of Food [ Time Frame: Baseline to Week 8 ]
  6. Duration of time between the last meal relative to dosing [ Time Frame: Baseline to Week 8 ]
    The difference between the time of day that participants ate their last meal and the time of day participants take their first dose.

  7. Characterization of Meals Relative to Dosing [ Time Frame: Baseline to Week 8 ]
  8. Change in Weekly Rate of Cataplexy Attacks [ Time Frame: Baseline to Week 8 ]
  9. Change in the Nausea Visual Analog Scale (NVAS) [ Time Frame: Baseline to Week 8 ]
    Tolerability associated with Xyrem and XYWAV will be measured based on an NVAS assessment administered electronically.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age

  1. Participant must be 18 to 80 years of age (inclusive), at the time of signing the informed consent. Type of Participant and Disease Characteristics
  2. 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.
  3. 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

  4. 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.
    • 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

  5. 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.

Exclusion Criteria:

Medical Conditions

  1. Have a diagnosis of narcolepsy, secondary to another medical condition (eg, central nervous system injury or lesion)
  2. Are currently prescribed a Xyrem regimen exceeding a dose of 9 grams nightly, or any single dose in excess of 6 grams.
  3. Have been diagnosed with restless leg syndrome (RLS) requiring treatment other than iron supplements
  4. Exhibit succinic semi-aldehyde dehydrogenase deficiency (SSADH)
  5. Have uncontrolled hypothyroidism
  6. Have a history of seizures, excluding early childhood non-pathological febrile seizures
  7. 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
  8. Show evidence of untreated or inadequately treated sleep-disordered breathing including:

    1. Presence of clinically significant and untreated obstructive or central sleep apnea (as determined by the investigator or documented previously); or one of the following:
    2. Apnea index (AI) >10 if on Obstructive Sleep Apnea (OSA) treatment or untreated, or
    3. Clinically significant hypoventilation, or
    4. 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.
  9. 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.
  10. Meet criteria for current major depression based on clinical interview
  11. Have any clinically relevant medical, behavioral, or psychiatric disorder (other than narcolepsy) that is associated with excessive sleepiness
  12. Have a history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  13. 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
  14. Display relevant suicidality as indicated by Columbia Suicide Severity Rating Scale (C-SSRS) evaluation at screening
  15. Display moderate to severe depression as indicated by the Participant Health Questionnaire - 9 (PHQ-9) at screening
  16. Are a female participant who is pregnant or breastfeeding

    Prior/Concomitant Therapy

  17. 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

  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794491


Contacts
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Contact: Director Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04794491    
Other Study ID Numbers: JZP258-401
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders