An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
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|ClinicalTrials.gov Identifier: NCT04794491|
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : July 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy||Drug: JZP-258||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose > 6 g
Other Name: XYWAV
- Number of Participants Converted from Xyrem to XYWAV [ Time Frame: Baseline to Week 8 ]
- 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
- 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.
- 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.
- Number of Changes from the First Dose and Regimen to Optimized Dose and Regimen [ Time Frame: Baseline to Week 8 ]
- Number of Participants Dosing Fasted Versus Dosing Without Consideration of Food [ Time Frame: Baseline to Week 8 ]
- 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.
- Characterization of Meals Relative to Dosing [ Time Frame: Baseline to Week 8 ]
- Change in Weekly Rate of Cataplexy Attacks [ Time Frame: Baseline to Week 8 ]
- 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.
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
|Contact: Director Clinical Trial Disclosure & Transparency||215-832-3750||ClinicalTrialDisclosure@JazzPharma.com|