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

PHASE4CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

June 20, 2022

Study Completion Date

June 20, 2022

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."

Trial Locations (9)

802-0084

YOU ARIYOSHI Sleep Clinic, Kitakyushu

830-0011

Kurume University Hospital, Kurume

830-0033

Hirota Clinic, Kurume

839-0863

Kurume University Medical Center, Kurume

854-0081

Kotorii Isahaya Hospital, Isahaya

849-0111

Ohshima Hospital, Nakatsukuma

140-0011

Sleep Support Clinic, Shinagawa

141-6003

Sleep & Stress Clinic, Shinagawa

862-0954

Kuwamizu Hospital, Kumamoto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

collaborator

Mebix Inc

INDUSTRY

lead

Kurume University

OTHER

NCT04742699 - An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia | Biotech Hunter | Biotech Hunter