A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
NCT ID: NCT03533114
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2018-11-27
2020-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JZP-258
JZP-258 at the stable dose and regimen for 2 weeks.
JZP-258
Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
Placebo
Placebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks.
Placebo Oral Solution
Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
Interventions
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JZP-258
Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
Placebo Oral Solution
Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
Eligibility Criteria
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Inclusion Criteria
2. Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria.
3. At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have ESS scores ≥ 11 (as assessed with a look-back period of 1 week).
4. If currently treated with Xyrem, must have documented clinical improvement of EDS after the initiation of Xyrem per Investigator's clinical judgment.
5. Average nightly total sleep time of ≥ 7 hours, per subject history. Average nightly total sleep time will be confirmed by Investigator's review of sleep diaries collected during the final 2 weeks of the Screening Period.
6. If currently treated with stimulants and / or alerting agents or nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose leading up to and throughout the Double-blind Randomized Withdrawal Period.
7. Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.
Exclusion Criteria
2. Evidence of untreated or inadequately treated sleep-disordered breathing.
3. Clinically significant parasomnias (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
4. Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Patients with depression under control are allowed per the judgment of the Investigator or the treating physician and the anti-depressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
5. Current suicidal risk as determined from history by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on C-SSRS, or any history of suicide attempt.
6. Occupation requiring nighttime shift work or variable shift work with early work start times or other occupations that could affect the safety of the subject per the judgment of the Investigator.
7. Treatment or planned treatment with any CNS sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opoids, barbiturates, phenytoin, melatonin, ethosuximide, medications containing valproic acid or its sodium salt, or any other medication in which the subject experiences sedation are prohibited during the study. Treatment must have been discontinued within 2 weeks or 5 half-lives, whichever is longer, prior to enrollment. The Investigator must ensure that discontinuation from these medications is medically supervised. Subjects must abstain from these medications during the study.
8. Current or past substance use disorder (including alcohol) according to DSM-5 criteria, or the subject is unwilling to refrain from consuming alcohol, cannabinoids, or prohibited medications during the study.
18 Years
75 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Wright Clinical Research, LLC
Birmingham, Alabama, United States
Coastal Clinical Research
Mobile, Alabama, United States
Mayo Clinic Building
Phoenix, Arizona, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States
Stanford Sleep Medicine Center
Redwood City, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Delta Waves, Inc.
Colorado Springs, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Bio-Medical Research, LLC
Miami, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
NeuroTrials Research
Atlanta, Georgia, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
SleepCare Research Institute d/b/a Clinical Research
Stockbridge, Georgia, United States
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Baystate Wesson Sleep Clinic
Springfield, Massachusetts, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
Clayton Sleep Institute, LLC
St Louis, Missouri, United States
Montefiore Medical Center/Sleep-Wake Disorders Center
The Bronx, New York, United States
American Health Research
Charlotte, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Research Carolina
Huntersville, North Carolina, United States
Clinical Research of Lake Norman
Mooresville, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Intrepid Research
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Sleep Medicine and Neuroscience Institute
Dublin, Ohio, United States
Lynne Health Science Institute
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Clinical Research of Charleston
Mt. Pleasant, South Carolina, United States
Neurology Clinic, PC
Cordova, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Anima Research Center
Alken, , Belgium
Antwerp University Hospital
Edegem, , Belgium
CHU UCL Namur site de Sainte Elisabeth
Namur, , Belgium
Nemocnice Ceske Budejovice a.s.
České Budějovice, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
VitalMed Oy
Helsinki, , Finland
CHU de Grenoble - Hôpital Michallon
Grenoble, , France
Hopital Roger Salengro
Lille, , France
Hopital Gui de Chauliac
Montpellier, , France
CHU Nantes - Hopital Nord Laënnec
Nantes, , France
Hopital Pitie-Salpetriere
Paris, , France
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Osrodek Badan Klinicznych CROMED
Poznan, , Poland
lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
Warsaw, , Poland
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Vithas Nuestra Señora de America
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Universitario Araba
Vitoria-Gasteiz, , Spain
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025 Jul 1;21(7):1209-1216. doi: 10.5664/jcsm.11662.
Morse AM, Dauvilliers Y, Arnulf I, Thorpy MJ, Foldvary-Schaefer N, Chandler P, Chen A, Hickey L, Black J, Bogan RK. Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. J Clin Sleep Med. 2023 Oct 1;19(10):1811-1822. doi: 10.5664/jcsm.10698.
Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001311-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JZP080-301
Identifier Type: -
Identifier Source: org_study_id