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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523503-30-00
Enrollment
51
Registered
2026-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy

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

DRUGE2086
DRUGTablets that match the E2086 tablets in both shape and appearance.

Sponsors

Eisai Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 10, 2026