Narcolepsy Clinical Trial
Official title:
An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV
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.
| Status | Recruiting |
| Enrollment | 89 |
| Est. completion date | July 1, 2025 |
| Est. primary completion date | June 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques Universitaires Saint-Luc | Bruxelles | |
| Belgium | Antwerp University Hospital (UZA) | Edegem | |
| Belgium | Private Practice RESPISOM Namur | Namur | |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
| France | CHU de Grenoble - Hôpital Albert Michallon | Grenoble | Isere |
| France | Hopital Roger Salengro - CHU Lille | Lille Cedex | Nord |
| France | Hopital Gui de Chauliac | Montpellier | Herault |
| France | CHU Nantes - Hôtel Dieu | Nantes | Loire Atlantique |
| Italy | IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB) | Bologna | |
| Italy | Ospedale San Raffaele (San Raffaele Turro) | Milano | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital General de Castellon | Castellon | |
| Spain | Hospital Universitario Clinico San Carlos | Madrid | |
| Spain | Hospital Universitario Araba - Sede Santiago | Vitoria | Alava |
| United States | Abington Neurological Associates, LTD | Abington | Pennsylvania |
| United States | FutureSearch Trials of Neurology | Austin | Texas |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | FWD Clinical Research | Boca Raton | Florida |
| United States | Meris Clinical Research, LLC | Brandon | Florida |
| United States | Intrepid Research, LLC | Cincinnati | Ohio |
| United States | Metro Health Medical Center | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Bogan Sleep Consultants, LLC | Columbia | South Carolina |
| United States | Science 37 | Culver City | California |
| United States | Ohio Sleep Medicine and Neuroscience | Dublin | Ohio |
| United States | M3 Wake Research | Encino | California |
| United States | Velocity Clinical Research, Greenville | Greenville | South Carolina |
| United States | Henderson Clinical Trials LLC | Henderson | Nevada |
| United States | Advanced Respiratory and Sleep Medicine, PLLC | Huntersville | North Carolina |
| United States | Long Beach Research Institute | Lakewood | California |
| United States | Sparrow Health System | Lansing | Michigan |
| United States | M3 Wake Research, Inc. | Las Vegas | Nevada |
| United States | Bryan Medical Center | Lincoln | Nebraska |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Sleep Practitioners, LLC | Macon | Georgia |
| United States | Nova Research Institute LLC | Miami | Florida |
| United States | Ocean Wellness Center | Miami | Florida |
| United States | Serenity Research Center LLC | Miami | Florida |
| United States | Saltzer Medical Group | Nampa | Idaho |
| United States | Neurocare, Inc | Newton | Massachusetts |
| United States | Florida Pediatric Research Institute, LLC | Orlando | Florida |
| United States | OHSU Hospital | Portland | Oregon |
| United States | M3 Wake Research, Inc. | Raleigh | North Carolina |
| United States | Stanford School of Medicine | Redwood City | California |
| United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
| United States | Sleep Therapy & Research Center | San Antonio | Texas |
| United States | Rady Children's Hospital | San Diego | California |
| United States | TriValley Sleep Center | San Ramon | California |
| United States | SDS Clinical Trials, Inc. | Santa Ana | California |
| United States | University of Arizona | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Jazz Pharmaceuticals |
United States, Belgium, Czechia, France, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change from baseline to EOT Visit on the daytime average SBP in mmHg | Baseline, Up to 6 weeks | ||
| Secondary | Change from baseline to EOT Visit on the seated resting average SBP in mmHg | Baseline, Up to 6 weeks | ||
| Secondary | Change from baseline to EOT Visit on the nighttime average SBP in mmHg | Baseline, Up to 6 weeks |
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