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Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

NCT02952820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 971

Last updated 2020-02-06

Study results available
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Summary

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

Conditions

  • Insomnia Disorder

Interventions

DRUG

lemborexant

DRUG

Placebo

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Eisai Medical Information · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-15
Primary Completion
2019-01-08
Completion
2019-01-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Finland
  • Germany
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02952820 on ClinicalTrials.gov