A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Narcolepsy
About this trial
This is an interventional treatment trial for Narcolepsy focused on measuring Narcolepsy Type 1, Narcolepsy Type 2, XYWAV, JZP258, Oxybate
Eligibility Criteria
Key Inclusion Criteria: Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent. Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Participants must have been receiving a dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) for a minimum of 6 consecutive weeks prior to screening. If currently treated with stimulants and/or alerting agents or other medications known to affect BP, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study. If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective. Key Exclusion Criteria: History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator. Presence of significant cardiovascular disease.
Sites / Locations
- Science 37Recruiting
- M3 Wake Research, Inc.Recruiting
- Long Beach Research Institute
- Stanford School of Medicine
- TriValley Sleep Center
- SDS Clinical Trials, Inc
- Meris Clinical Research
- Nova Research Institute LLC
- Serenity Research Center LLC
- Florida Pediatric Research Institute, LLCRecruiting
- Sleep Practioners , LLC
- Saltzer Medical GroupRecruiting
- University of Louisville
- Neurocare, Inc.Recruiting
- Sparrow Health System
- Bryan Medical Center
- Henderson Clinical Trials, LLC
- M3 Wake Research, Inc.Recruiting
- Advanced Respiratory and Sleep Medicine, LLCRecruiting
- M3 Wake Research, Inc.Recruiting
- Intrepid Research, LLCRecruiting
- University Hospitals Cleveland Medical Center
- Ohio Sleep Medicine and NeuroscienceRecruiting
- OHSU Hospital
- Abington Neurological Associates, LTD
- Bogan Sleep Consultants, LLCRecruiting
- Velocity Clinical Research, Greenville
- Clinical Research of Rock Hill
- FutureSearch Trials of Neurology
- Sleep Therapy and Research CenterRecruiting
- Cliniques Universitaires Saint-Luc
- Antwerp University Hospital
- Private Practice RESPISOM Namur
- Vseobecna fakultni nemocnice v Praze
- Hopital Gui de Chauliac
- CHU de Grenoble - Hôpital Albert Michallon
- IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
- Ospedale San Raffaele (San Raffaele Turro)
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Hospital Universitario Araba - Sede Santiago
- Hospital Universitari Vall d'Hebron
- Hospital General de Castellon
- Hospital Universitario Clinico San Carlos
Arms of the Study
Arm 1
Experimental
JZP258
Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.