Narcolepsy
Conditions
Brief summary
Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2
Detailed description
Weekly Cataplexy Rate (WCR) of E2086 Compared With Placebo at Week 4 in Participants With NT1, Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 4 for E2086 Compared With Placebo in Participants With NT1 and NT2, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Participants With NT1 and NT2, Number of Participants With Markedly Abnormal Laboratory Values in Participants With NT1 and NT2, Number of Participants With Clinically Significant Changes in Vital Sign Values in Participants With NT1 and NT2, Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters in Participants With NT1 and NT2, Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) in Participants 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 Participants With NT1 and NT2, Mean Change From Baseline in Day-time and Night-time BP Measured by ABPM in Participants 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)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly Cataplexy Rate (WCR) of E2086 Compared With Placebo at Week 4 in Participants With NT1, Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 4 for E2086 Compared With Placebo in Participants With NT1 and NT2, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Participants With NT1 and NT2, Number of Participants With Markedly Abnormal Laboratory Values in Participants With NT1 and NT2, Number of Participants With Clinically Significant Changes in Vital Sign Values in Participants With NT1 and NT2, Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters in Participants With NT1 and NT2, Number of Participants With Suicidality as Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) in Participants 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 l | — |