MedTrace Logo

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

NCT03001557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-05-17

Study results available
· View outcomes & findings →

Summary

This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.

Conditions

  • Irregular Sleep-Wake Rhythm Disorder

Interventions

DRUG

Lemborexant 2.5 mg

Lemborexant 2.5 mg tablets

DRUG

Lemborexant 5 mg

Lemborexant 5 mg tablets

DRUG

Lemborexant 10 mg

Lemborexant 10 mg tablets

DRUG

Lemborexant 15 mg

Lemborexant 5 mg and 10 mg tablets

DRUG

Lemborexant-matched placebo

Lemborexant-matched placebo tablets

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2018-07-26
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States
  • Japan
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001557 on ClinicalTrials.gov