A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy

Conditions

• Narcolepsy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• E2086 — DRUG
  E2086 oral tablets.
• Placebo — DRUG
  E2086 matching placebo tablet.

Study Details

The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \[MWTs\]).

Key Dates

Start date

Mar 26, 2026

Status verified

Mar 2026

Primary completion

Feb 14, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: NT1 Participants: Placebo
  Participants with NT1 will be randomly assigned to receive one E2086 matched placebo tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
• Experimental: NT1 Participants: E2086
  Participants with NT1 will be randomly assigned to receive one E2086 tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
• Placebo Comparator: NT2 Participants: Placebo
  Participants with NT2 will be randomly assigned to receive one E2086 matched placebo tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.
• Experimental: NT2 Participants: E2086
  Participants with NT2 will be randomly assigned to receive one E2086 tablet, orally, once daily for 4 weeks during each of the E2086 low-, middle-, and high-dose-matched treatment periods. A washout period of at least 7 days will be included between dose levels, for a total of approximately 14 weeks of treatment.

Primary Outcome Measure

Change from Baseline to Week 4 in MSL for E2086 Compared With Placebo Across Four MWTs in Participants With NT1 and NT2 [ Time Frame: Baseline and Week 4 ]

Central Contacts

• Eisai Medical Information
  +1-888-274-2378
  [email protected]

Locations (17)

Find similar trials in Santa Ana, CA

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