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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01681121 | A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy | PHASE2 | COMPLETED | 93 | — | — | Sep 1, 2012 | Aug 1, 2013 | May 28, 2021 | 28 | United States |
| NCT01485770 | A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness | PHASE2 | COMPLETED | 33 | — | — | Dec 1, 2011 | May 1, 2012 | Jul 6, 2021 | 10 | United States |
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.
The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Improvement was defined as a CGI-rating of 1, 2, or 3.
The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
| Arm | Type | Description |
|---|---|---|
| ADX-N05 | EXPERIMENTAL | ADX-N05 to be taken once a day for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo to match ADX-N05 to be taken once a day for 12 weeks |
| Placebo, Then ADX-N05 | EXPERIMENTAL | Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2). They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4). |
| ADX-N05, Then Placebo | PLACEBO_COMPARATOR | Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2). They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4). |
| Name | Type | Description |
|---|---|---|
| ADX-N05 | DRUG | 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks |
| Placebo | DRUG | One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks |
Inclusion Criteria: * Diagnosis of narcolepsy * Good general health * Willing and able to comply with the study design and schedule and other requirements Exclusion Criteria: * If female, pregnant or lactating * Customary bedtime later than midnight * History of significant medical condition, beh...