Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mazindol · 3 trials · 6 indications
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.
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.
| Arm | Type | Description |
|---|---|---|
| NLS-2 (mazindol extended release) | EXPERIMENTAL | NLS-2 (mazindol extended release) administered once a day. |
| Placebo | PLACEBO_COMPARATOR | Dosed orally, once daily for up to 4 weeks |
| Mazindol Controlled Release | EXPERIMENTAL | Mazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily. |
| Name | Type | Description |
|---|---|---|
| Mazindol | DRUG | Drug: NLS-2 |
| mazindol extended release | DRUG | Dosed orally, once daily for up to 3 weeks |
| Placebo | DRUG | Dosed orally, once daily for up to 4 weeks. |
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...