An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

Summary

This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current medication.

Transition from Following 4 regimens of interest will be investigated; Z-Drug monotherapy, suvorexant (SUV) monotherapy, SUV and benzodiazepine receptor agonists (BZRA) combination therapy, and ramelteon (RMT) and BZRA combination therapy. Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled.

As a comprehensive indicator of patient satisfaction including treatment efficacy and safety, the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning; thus important initial response after transitioning will be evaluated as a primary endpoint. In addition, as a secondary purpose, the treatment continuation, efficacy and tolerability, and the treatment impression for insomnia (Patient Global Impression of Insomnia) for 14 weeks after transitioning will be assessed.

Conditions

• Insomnia

Interventions

DRUG

Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)

1. Pretreatment phase: Continue pre-registration treatment (Z-drug monotherapy) without LEM. 2. First treatment phase: Administer LEM 5 mg/day as a substitute for Z-Drug. Increasing LEM dose to 10 mg/day is allowed. 3. Maintenance phase: Succeed the treatment from the first treatment phase. Changing LEM dose is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.

DRUG

Lemborexant (LEM) 5 mg (SUV-mono cohort)

1. Pretreatment phase: Continue pre-registration treatment (SUV monotherapy) without LEM. 2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV. Increasing to LEM dose to 10 mg/day is allowed. 3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed.

DRUG

Lemborexant (LEM) 5 mg (SUV-combination cohort)

1. Pretreatment phase: Continue pre-registration treatment (SUV and BZRA combination therapy) without LEM. 2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed. 3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.

DRUG

Lemborexant (LEM) 5 mg (RMT-combination cohort)

1. Pretreatment phase: Continue pre-registration treatment (RMT and BZRA combination therapy) without LEM. 2. First treatment phase: Administer LEM 5 mg/day as a substitute for RMT and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed. 3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.

Sponsors & Collaborators

• Eisai Inc.

  collaborator INDUSTRY

• Mebix Inc

  collaborator INDUSTRY

• Kurume University

  lead OTHER

Principal Investigators

• Motohiro Ozone · Kurume University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-24

Primary Completion

2022-06-20

Completion

2022-06-20

Countries

• Japan

Study Locations