Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03533114 | A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension | PHASE3 | COMPLETED | 154 | — | — | Nov 27, 2018 | Dec 18, 2020 | Nov 24, 2021 | 63 | United States, Belgium +6 |
The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness.
| Arm | Type | Description |
|---|---|---|
| JZP-258 | EXPERIMENTAL | JZP-258 at the stable dose and regimen for 2 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks. |
| Name | Type | Description |
|---|---|---|
| JZP-258 | DRUG | Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period. |
| Placebo Oral Solution | DRUG | 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. |
Inclusion Criteria: 1. Male or female between 18 and 75 years of age, inclusive, at the time of consent. 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 n...