Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADX-N05 · 2 trials · 1 indication
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...
ADX-N05 is an investigational small molecule being developed for the treatment of narcolepsy, specifically to address excessive daytime sleepiness. It is currently in Phase 2 clinical development and has not been approved by the FDA. Two Phase 2 trials have been completed to evaluate its safety and effectiveness in patients with narcolepsy.
ADX-N05 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in treating excessive daytime sleepiness associated with narcolepsy.
ADX-N05 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both of which were randomized, double-blind, and placebo-controlled. The drug is investigational and has not received FDA approval. Its safety and effectiveness are still being evaluated in clinical studies.
ADX-N05 has been studied in two completed Phase 2 clinical trials. The first, NCT01485770, enrolled 33 participants, and the second, NCT01681121, enrolled 93 participants. Both trials were conducted in the United States, involved adults aged 18 years and older, and focused on treating excessive daytime sleepiness in narcolepsy.
No, ADX-N05 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of excessive daytime sleepiness in narcolepsy. Two Phase 2 trials have been completed, but the drug has not yet received regulatory approval.