A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Public ClinicalTrials.gov record NCT03533114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Study identification
- NCT ID
- NCT03533114
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 154 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2018 (Actual)
- Primary completion
- Jun 12, 2020 (Actual)
- Completion
- Dec 18, 2020 (Actual)
- Last update posted
- Nov 24, 2021
2018 – 2020
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| Wright Clinical Research, LLC | Birmingham | Alabama | 35243 | — |
| Coastal Clinical Research | Mobile | Alabama | 36608 | — |
| Mayo Clinic Building | Phoenix | Arizona | 85054 | — |
| Southern California Institute for Respiratory Diseases, Inc. | Los Angeles | California | 90048 | — |
| Stanford Sleep Medicine Center | Redwood City | California | 94063 | — |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Delta Waves, Inc. | Colorado Springs | Colorado | 80918 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Suncoast Research Group | Miami | Florida | 33135 | — |
| Bio-Medical Research, LLC | Miami | Florida | 33184 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| NeuroTrials Research | Atlanta | Georgia | 30342 | — |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | — |
| SleepCare Research Institute d/b/a Clinical Research | Stockbridge | Georgia | 30281 | — |
| Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| Baystate Wesson Sleep Clinic | Springfield | Massachusetts | 01199 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Clinical Neurophysiology Services, P.C. | Sterling Heights | Michigan | 48314 | — |
| Minnesota Lung Center | Minneapolis | Minnesota | 55435 | — |
| Clayton Sleep Institute, LLC | St Louis | Missouri | 63146 | — |
| Montefiore Medical Center/Sleep-Wake Disorders Center | The Bronx | New York | 10467 | — |
| American Health Research | Charlotte | North Carolina | 28207 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Research Carolina | Huntersville | North Carolina | 28078 | — |
| Clinical Research of Lake Norman | Mooresville | North Carolina | 28117 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| Intrepid Research | Cincinnati | Ohio | 45245 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine and Neuroscience Institute | Dublin | Ohio | 43017 | — |
| Lynne Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| Clinical Research of Charleston | Mt. Pleasant | South Carolina | 29464 | — |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03533114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 24, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03533114 live on ClinicalTrials.gov.