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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05055024 | An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy | PHASE2 | COMPLETED | 52 | — | — | Oct 26, 2021 | Jan 19, 2023 | Mar 13, 2023 | 22 | United States |
Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
| Arm | Type | Description |
|---|---|---|
| NLS-2 (mazindol extended release) | EXPERIMENTAL | NLS-2 (mazindol extended release) administered once a day. |
| Name | Type | Description |
|---|---|---|
| Mazindol | DRUG | Drug: NLS-2 |
Inclusion Criteria: * The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6; * The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study; * Biological females of childbearing potential must agree t...