A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy

Condition studied

Narcolepsy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Subjects With NT1 and NT2

Endpoint detail

Weekly Cataplexy Rate (WCR) of E2086 Compared With Placebo at Week 4 in Subjects With NT1, Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 4 for E2086 Compared With Placebo in Subjects With NT1 and NT2, Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Subjects With NT1 and NT2, Number of Subjects With Markedly Abnormal Laboratory Values in Subjects With NT1 and NT2, Number of Subjects With Clinically Significant Changes in Vital Sign Values in Subjects With NT1 and NT2, Number of Subjects With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters in Subjects With NT1 and NT2, Number of Subjects With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) in Subjects With NT1 and NT2, Mean Change From Baseline in 24-hours Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) up to Week 4 of each dose level in Subjects With NT1 and NT2, Mean Change From Baseline in Day-time and Night-time BP Measured by ABPM in Subjects With NT1 and NT2, Cmax: Maximum Observed Plasma Concentration of E2086 and its Metabolite M1, Tmax: Time to Reach Cmax of E2086 and its Metabolite M1, AUC(0-24h): Area Under the Plasma Concentration–time Curve From Zero Time to 24 Hours of E2086 and its Metabolite M1, t½: Terminal Phase Half-life of E2086 and its Metabolite M1, MRp: Metabolite Ratio of AUC(0-t)