Trials / Completed
CompletedNCT03533114
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JZP-258 | Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period. |
| DRUG | 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. |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2020-06-12
- Completion
- 2020-12-18
- First posted
- 2018-05-22
- Last updated
- 2021-11-24
- Results posted
- 2021-11-24
Locations
63 sites across 8 countries: United States, Belgium, Czechia, Finland, France, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03533114. Inclusion in this directory is not an endorsement.