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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05113745 | A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) | PHASE3 | COMPLETED | 68 | — | — | Oct 20, 2021 | Nov 15, 2024 | Nov 13, 2025 | 25 | United States, Canada |
| NCT05059223 | A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy | PHASE3 | COMPLETED | 90 | — | — | Sep 15, 2021 | Mar 15, 2024 | May 28, 2026 | 50 | United States, Canada |
| NCT03881852 | Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) | PHASE2 | COMPLETED | 21 | — | — | Jan 30, 2019 | Nov 27, 2019 | Aug 24, 2023 | 14 | United States |
Average number of cataplexy attacks per week
Presented as LSmeans. A positive change is indicative of improvement.
| Arm | Type | Description |
|---|---|---|
| AXS-12 (reboxetine) | EXPERIMENTAL | * Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period |
| Placebo | PLACEBO_COMPARATOR | Up to 4 weeks in randomized double-blind period |
| Name | Type | Description |
|---|---|---|
| AXS-12 (reboxetine) | DRUG | AXS-12 tablets, taken twice daily |
| Placebo | DRUG | Placebo tablets, taken twice daily |
Inclusion Criteria: * Completed the treatment period of Study AXS-12-301 * Willing and able to comply with the study requirements Exclusion Criteria: * Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigato...