Phase
Condition
Narcolepsy
Treatment
JZP258
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants must be 18 to 70 years of age inclusive, at the time of signing theinformed consent.
Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meetsInternational Classification of Sleep Disorders (ICSD)-3 or Diagnostic andStatistical 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 6consecutive weeks prior to screening.
If currently treated with stimulants and/or alerting agents or other medicationsknown to affect BP, participant must have been taking the same dosing regimen for atleast 2 months prior to screening and agree to take the same dose throughout thestudy.
If currently taking stable doses of antihypertensive therapies, participant mustmaintain these treatments at the same dose throughout the study unless otherwiseadvised by their medical care
Participant is male or female. A female participant is eligible to participate ifshe is not pregnant or breastfeeding, if she is a woman of nonchildbearing potentialor is a woman of childbearing potential and using a contraceptive method that ishighly effective.
Exclusion
Key Exclusion Criteria:
History or presence of any acutely unstable medical condition, behavioral orpsychiatric disorder (including active suicidal ideation), or surgical history thatcould affect the safety of the participant or interfere with study assessments orthe ability of the participant to complete the study based on the judgment of theinvestigator.
Presence of significant cardiovascular disease or cardiovascular condition that inthe investigator's opinion may jeopardize participant safety in the study, includingscreening ECG results.
Presence of atrial fibrillation detected on screening electrocardiogram (ECG).
Presence of resistant hypertension.
Study Design
Connect with a study center
Cliniques Universitaires Saint-Luc
Brussel, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Antwerp University Hospital
Edegem, 2650
BelgiumSite Not Available
Antwerp University Hospital (UZA)
Edegem, 2650
BelgiumSite Not Available
Private Practice RESPISOM Namur
Namur, 5101
BelgiumSite Not Available
Vseobecna fakultni nemocnice v Praze
Praha 2, 128 21
CzechiaSite Not Available
Hopital Gui de Chauliac
Montpellier, Herault 34295
FranceSite Not Available
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere 38043
FranceSite Not Available
CHU Nantes - Hôtel Dieu
Nantes, Loire Atlantique 44093
FranceSite Not Available
Hopital Roger Salengro - CHU Lille
Lille Cedex, Nord 59037
FranceSite Not Available
IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
Bologna, 40139
ItalySite Not Available
Ospedale San Raffaele (San Raffaele Turro)
Milano, 20127
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, 00133
ItalySite Not Available
Hospital Universitario Araba - Sede Santiago
Vitoria, Alava 01004
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital General de Castellon
Castellon, 12004
SpainSite Not Available
Hospital General de Castellon
Castillón, 12004
SpainSite Not Available
Hospital Universitario Clinico San Carlos
Madrid, 28040
SpainSite Not Available
University of Arizona
Tucson, Arizona 85721
United StatesSite Not Available
Science 37
Culver City, California 90230
United StatesSite Not Available
M3 Wake Research
Encino, California 91436
United StatesSite Not Available
M3 Wake Research, Inc.
Encino, California 91436
United StatesActive - Recruiting
So Cal Clinical Research
Huntington Beach, California 92647
United StatesSite Not Available
Long Beach Research Institute
Lakewood, California 90805
United StatesSite Not Available
Stanford School of Medicine
Redwood City, California 94063
United StatesSite Not Available
Rady Children's Hospital
San Diego, California 92123
United StatesSite Not Available
Sleep Medicine Specialists of California
San Ramon, California 94583
United StatesSite Not Available
TriValley Sleep Center
San Ramon, California 94583
United StatesSite Not Available
SDS Clinical Trials, Inc
Santa Ana, California 92705
United StatesSite Not Available
SDS Clinical Trials, Inc.
Santa Ana, California 92705
United StatesSite Not Available
FWD Clinical Research
Boca Raton, Florida 33486
United StatesSite Not Available
Meris Clinical Research
Brandon, Florida 33511
United StatesSite Not Available
Meris Clinical Research, LLC
Brandon, Florida 33511
United StatesSite Not Available
Nova Research Institute LLC
Miami, Florida 33125
United StatesSite Not Available
Ocean Wellness Center
Miami, Florida 33169
United StatesSite Not Available
Serenity Research Center LLC
Miami, Florida 33176
United StatesSite Not Available
Florida Pediatric Research Institute, LLC
Orlando, Florida 32804
United StatesSite Not Available
Sleep Practioners , LLC
Macon, Georgia 31210
United StatesSite Not Available
Sleep Practitioners, LLC
Macon, Georgia 31210
United StatesSite Not Available
Saltzer Medical Group
Nampa, Idaho 83686
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Neurocare, Inc
Newton, Massachusetts 02459
United StatesSite Not Available
Neurocare, Inc.
Newton, Massachusetts 02459
United StatesActive - Recruiting
Sparrow Health System
Lansing, Michigan 48911
United StatesSite Not Available
Bryan Medical Center
Lincoln, Nebraska 68506
United StatesSite Not Available
Henderson Clinical Trials LLC
Henderson, Nevada 89052
United StatesSite Not Available
Henderson Clinical Trials, LLC
Henderson, Nevada 89052
United StatesSite Not Available
M3 Wake Research, Inc.
Las Vegas, Nevada 89106
United StatesSite Not Available
Advanced Respiratory and Sleep Medicine, LLC
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina 28078
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesSite Not Available
Intrepid Research, LLC
Cincinnati, Ohio 45245
United StatesSite Not Available
Metro Health Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio Sleep Medicine and Neuroscience
Dublin, Ohio 43017
United StatesSite Not Available
OHSU Hospital
Portland, Oregon 97239
United StatesSite Not Available
Abington Neurological Associates, LTD
Abington, Pennsylvania 19001
United StatesSite Not Available
Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201
United StatesSite Not Available
Velocity Clinical Research, Greenville
Greenville, South Carolina 29615
United StatesSite Not Available
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
United StatesSite Not Available
FutureSearch Trials of Neurology
Austin, Texas 78731
United StatesSite Not Available
Sleep Therapy & Research Center
San Antonio, Texas 78229
United StatesSite Not Available
Sleep Therapy and Research Center
San Antonio, Texas 78229
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.