0593 Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy

Abstract Introduction Efficacy secondary outcome measure Functional Outcomes of Sleep Questionnaire, Short Version (FOSQ-10] was collected in the Phase 2 (POLARIS, NLS-1021), multicenter (n=21) study mazindol ER adult participants with narcolepsy type 1 (NT1) or (NT2) (ClinicalTrials.gov Identifier: NCT04923594). Methods Adults diagnosed NT1 NT2 who were washed out medications at baseline included into study. Patients treated (NLS-2) once-daily mg for one week and 3 thereafter matching placebo (PBO) on a 1:1 ratio. Throughout study, FOSQ-10 assessed compared vs. PBO scores baseline. Treatment emergent adverse events (TEAEs) assessed. Results Sixty-seven randomized (NT1 33.3% NLS-2 group versus 35.3% PBO). At baseline, mean [SD] score 23.1 (5.5) arm 23.7 (7.1) arm. After four weeks treatment, there an increase 4.1 (9.0) vs 0.4 (6.9) (p = 0.04). Similar magnitude effect seen patients (D +4.7, p 0.08, n 20) as well +3.0, 0.20, 44) No serious reported. The most frequently reported TEAEs (>5%) dry mouth, nausea, decreased appetite tachycardia. Conclusion Mazindol resulted significant improvements functional These results support efficacy cataplexy attacks, patients, sleepiness, patients. Support (if any) NLS Pharmaceutics