Clinical trial NCT05869773: A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Official title: An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Narcolepsy
Keywords: Narcolepsy Type 1
Narcolepsy Type 2
XYWAV
JZP258
Oxybate
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.


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 total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing 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 or cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study, including screening ECG results.
* Presence of atrial fibrillation detected on screening electrocardiogram (ECG).
* Presence of resistant hypertension.

Primary outcomes:
measure: Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg
timeFrame: Baseline, Up to 6 weeks
Secondary outcomes:
measure: Change from baseline to EOT Visit on the daytime average SBP in mmHg
timeFrame: Baseline, Up to 6 weeks
measure: Change from baseline to EOT Visit on the seated resting average SBP in mmHg
timeFrame: Baseline, Up to 6 weeks
measure: Change from baseline to EOT Visit on the nighttime average SBP in mmHg
timeFrame: Baseline, Up to 6 weeks
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Science 37
state: California
city: Encino
country: United States
facility: M3 Wake Research
state: California
city: Huntington Beach
country: United States
facility: So Cal Clinical Research
state: California
city: Lakewood
country: United States
facility: Long Beach Research Institute
state: California
city: Redwood City
country: United States
facility: Stanford School of Medicine
state: California
city: San Ramon
country: United States
facility: TriValley Sleep Center
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Boca Raton
country: United States
facility: FWD Clinical Research
state: Florida
city: Brandon
country: United States
facility: Meris Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Ocean Wellness Center
state: Florida
city: Miami
country: United States
facility: Serenity Research Center LLC
state: Florida
city: Orlando
country: United States
facility: Florida Pediatric Research Institute, LLC
state: Florida
city: Macon
country: United States
facility: Sleep Practitioners, LLC
state: Georgia
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Newton
country: United States
facility: Neurocare, Inc
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
city: Henderson
country: United States
facility: Henderson Clinical Trials LLC
state: Nevada
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine, PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Intrepid Research, LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine and Neuroscience
state: Ohio
city: Portland
country: United States
facility: OHSU Hospital
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates, LTD
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
city: Edegem
country: Belgium
facility: Antwerp University Hospital (UZA)
city: Namur
country: Belgium
facility: Private Practice RESPISOM Namur
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
state: Herault
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
state: Isere
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
state: Loire Atlantique
city: Bologna
country: Italy
facility: IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
city: Milano
country: Italy
facility: Ospedale San Raffaele (San Raffaele Turro)
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Vitoria
country: Spain
facility: Hospital Universitario Araba - Sede Santiago
state: Alava
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Castellon
country: Spain
facility: Hospital General de Castellon
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
Study officials:
References: