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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05914194 | A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 | PHASE3 | NOT YET_RECRUITING | 48 | — | — | Jul 15, 2024 | Jul 30, 2025 | May 21, 2024 | - | — |
Cataplexy episodes is a clinical outcome measure that assesses the frequency of cataplexy episodes.
| Arm | Type | Description |
|---|---|---|
| NLS-2 | EXPERIMENTAL | Participants will receive a single NLS-2 tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single NLS-2 placebo matching tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| Name | Type | Description |
|---|---|---|
| NLS-2 | DRUG | Participants will receive NLS-2 tablets orally. |
| Placebo | DRUG | Participants will receive NLS-2 matching placebo tablets orally. |
Key Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria. * Willing and able to safely discontinue all pr...