Effectiveness and safety of lemborexant in patients with Insomnia
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder
IRAS ID
208154
Contact name
Ian Edward Smith
Contact email
Sponsor organisation
Eisai Ltd.
Eudract number
2015-004347-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 11 days
Research summary
Insomnia is a sleep disorder which is a widespread problem in industrialised nations, with approximately 30% of the population having symptoms and at least 6% meeting diagnostic criteria for insomnia meriting treatment.
This is a Phase 3, multicentre, randomised, double-blind, placebo-controlled, active comparator, parallel-group study of an investigational treatment lemborexant (or E2006) in participants 55 years and older with Insomnia Disorder. At least 60% of the study population will be age 65 years or older. The study will be conducted in approximately 90 sites globally. Approximately 950 participants will be randomized.
The main goal of this study is to compare the effectiveness of two strengths of lemborexant with another drug called zolpidem tartrate extended release (zolpidem ER), also known as Ambien CR®, and placebo (dummy tablet). Zolpidem ER is approved for the treatment of insomnia in the U.S.A., it is not approved in the European Union.
Each participant will be in the study for around 11.5 weeks. The study involves a screening period, run-in period, baseline period, treatment period, follow-up period and end of study visit.
Participants will be randomly assigned (like the flip of a coin) to receive one of four treatment groups:
• 1 x 5mg tablet of lemborexant and 1 x tablet zolpidem ER matching placebo, or
• 1 x 10mg tablet lemborexant and 1 x tablet zolpidem ER matching placebo, or
• 1 x tablet lemborexant matching placebo and 1 x 6.25mg tablet zolpidem ER, or
• 1 x tablet lemborexant matching placebo and 1 x tablet zolpidem ER matching placebo
Participants will have a 5 in 9 chance of receiving lemborexant.Participants will undergo procedures including: medical history, physical exams, vital signs, blood and urine tests, ECG (electrical tracing of the heart), questionnaires, assessments, electronic sleep diary completion, review of adverse events, and 7 overnight sleep studies (Polysomnograms or PSGs).
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0337
Date of REC Opinion
21 Oct 2016
REC opinion
Further Information Favourable Opinion