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

Sponsor

Jazz Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05869773

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy	Drug: JZP258	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

89 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JZP258 Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.	Drug: JZP258 0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution Other Names: XYWAV

Arm

Intervention/Treatment

Experimental: JZP258

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

Drug: JZP258

0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution

Other Names:

XYWAV

Outcome Measures

Primary Outcome Measures

Change from baseline to End of Treatment (EOT) Visit on the 24-hour average Systolic Blood Pressure (SBP) in mmHg [Baseline, Up to 6 weeks]

Secondary Outcome Measures

Change from baseline to EOT Visit on the daytime average SBP in mmHg [Baseline, Up to 6 weeks]
Change from baseline to EOT Visit on the seated resting average SBP in mmHg [Baseline, Up to 6 weeks]
Change from baseline to EOT Visit on the nighttime average SBP in mmHg [Baseline, Up to 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M3 Wake Research	Encino	California	United States	91436
2	SDS Clinical Trials, Inc	Santa Ana	California	United States	92705
3	Meris Clinical Research	Brandon	Florida	United States	33511
4	Florida Pediatric Research Institute, LLC	Orlando	Florida	United States	32804
5	Advanced Respiratory and Sleep Medicine, LLC	Huntersville	North Carolina	United States	28078
6	Intrepid Research, LLC	Cincinnati	Ohio	United States	45245
7	Ohio Sleep Medicine and Neuroscience	Dublin	Ohio	United States	43017
8	Bogan Sleep Consultants, LLC	Columbia	South Carolina	United States	29201
9	FutureSearch Trials of Neurology	Austin	Texas	United States	30901
10	Sleep Therapy and Research Center	San Antonio	Texas	United States	78229
11	Antwerp University Hospital	Edegem		Belgium	2650
12	Private Practice RESPISOM Namur	Namur		Belgium	05101
13	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	12821
14	Hopital Gui de Chauliac	Montpellier	Herrault	France	34295
15	IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)	Bologna		Italy	40139
16	Ospedale San Raffaele (San Raffaele Turro)	Milano		Italy	20127
17	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma		Italy	00133
18	Hospital Universitario Clinico San Carlos	Madrid		Spain	28040