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A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Primary Purpose

Narcolepsy

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
JZP258
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

JZP258

Arm Description

Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.

Outcomes

Primary Outcome Measures

Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg

Secondary Outcome Measures

Change from baseline to EOT Visit on the daytime average SBP in mmHg
Change from baseline to EOT Visit on the seated resting average SBP in mmHg
Change from baseline to EOT Visit on the nighttime average SBP in mmHg

Full Information

First Posted
May 12, 2023
Last Updated
October 16, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05869773
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
Keywords
Narcolepsy Type 1, Narcolepsy Type 2, XYWAV, JZP258, Oxybate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JZP258
Arm Type
Experimental
Arm Description
Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
JZP258
Other Intervention Name(s)
XYWAV
Intervention Description
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Primary Outcome Measure Information:
Title
Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg
Time Frame
Baseline, Up to 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to EOT Visit on the daytime average SBP in mmHg
Time Frame
Baseline, Up to 6 weeks
Title
Change from baseline to EOT Visit on the seated resting average SBP in mmHg
Time Frame
Baseline, Up to 6 weeks
Title
Change from baseline to EOT Visit on the nighttime average SBP in mmHg
Time Frame
Baseline, Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Manager
Email
JZP258_406_407_InfoRequest@JazzPharma.com
Facility Information:
Facility Name
Science 37
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
M3 Wake Research, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Beach Research Institute
City
Lakewood
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stanford School of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
TriValley Sleep Center
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SDS Clinical Trials, Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Meris Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Nova Research Institute LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Withdrawn
Facility Name
Serenity Research Center LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Pediatric Research Institute, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Practioners , LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Recruiting
Facility Name
Sparrow Health System
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bryan Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Henderson Clinical Trials, LLC
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
M3 Wake Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Respiratory and Sleep Medicine, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Name
Intrepid Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ohio Sleep Medicine and Neuroscience
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Individual Site Status
Recruiting
Facility Name
OHSU Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Abington Neurological Associates, LTD
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Private Practice RESPISOM Namur
City
Namur
ZIP/Postal Code
05101
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12821
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Hopital Gui de Chauliac
City
Montpellier
State/Province
Herrault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Grenoble - Hôpital Albert Michallon
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38043
Country
France
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Raffaele (San Raffaele Turro)
City
Milano
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Araba - Sede Santiago
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General de Castellon
City
Castillón
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

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