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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02720744 | Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy | PHASE3 | COMPLETED | 212 | — | — | Nov 17, 2016 | Mar 25, 2020 | Mar 22, 2022 | 57 | United States, Australia +4 |
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
| Arm | Type | Description |
|---|---|---|
| Sodium Oxybate | EXPERIMENTAL | Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate. |
| Placebo | PLACEBO_COMPARATOR | Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo. |
| Name | Type | Description |
|---|---|---|
| FT218 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Male or female subjects 16 years of age or older 2. Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally auth...