A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

NCT04009577 | Completed Phase 3 Results FDA Drug

• 1 other identifier: E2006-A001-312
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 17

Brief Summary

The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM.

Conditions

Insomnia

Keywords

Insomnia; Sleep Initiation and Maintenance Disorders; Insomnia Disorder; Sleeplessness; E2006; Zolpidem; Lemborexant

Outcome Measures

Primary Outcomes (1)

• Percentage of Overall Participants Who Transitioned to LEM at the End of the Titration Period of Core Study

  Transition to LEM was defined as participant who remained on LEM at the end of the 2-week titration period and either 1) entered the extension phase, or 2) chooses to not enter the extension phase for reasons not related to LEM (including, but not limited to, time commitment related to the study, study-related travel expenses or preference to continue insomnia management with another health care provider).

  Up to 2 Weeks

Secondary Outcomes (4)

• Percentage of Participants Who Transitioned to LEM at the End of the 2-Week Titration Period of Core Study Within Each Cohort

  Up to 2 Weeks

• Percentage of Participants in the LEM5 Treatment Groups With Dose Increasing to LEM10 at the End of the Titration Period of Core Study by Cohort and Overall

  Up to 2 Weeks

• Percentage of Participants in LEM10 Treatment Group With Dose Decreasing to LEM5 at the End of the Titration Period of Core Study in Cohort 2

  Up to 2 Weeks

• Percentage of Participants With Positive Medication Effect Rating on Each Patient Global Impression of Insomnia (PGI-I) Item at the End of the 2-Week Titration Period of Core Study by Cohort and Overall Using End of the Titration Period Treatment

  Up to 2 Weeks

Study Arms (3)

Cohort 1 (LEM 5 mg)

EXPERIMENTAL

Participants who were taking zolpidem tartrate (ZOL) at least 3 but fewer than 5 nights per week, for each of at least 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks. Participants who meet both criteria for intermittent (Cohort 1) and frequent ZOL use (Cohort 2A and 2B) for 1 week each of the last 2 weeks of the 3-week Screening Period will be assigned to Cohort 1 and also will receive LEM 5mg.

Drug: LEM 5 mg

Cohort 2A (LEM 5 mg)

EXPERIMENTAL

Participants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 5 mg administered as a tablet, orally for up to 2 weeks.

Drug: LEM 5 mg

Cohort 2B (LEM 10 mg)

EXPERIMENTAL

Participants who were taking ZOL at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period, will initially receive LEM 10 mg administered as a tablet, orally for up to 2 weeks.

Drug: LEM 10 mg

Interventions

LEM 5 mg DRUG

LEM tablet.

Also known as: E2006, Lemborexant

Cohort 1 (LEM 5 mg); Cohort 2A (LEM 5 mg)

LEM 10 mg DRUG

LEM tablet.

Also known as: E2006, Lemborexant

Cohort 2B (LEM 10 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-5) criteria for Insomnia Disorder, either currently or prior to zolpidem use, as follows:
• Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
• Frequency of complaint \>=3 times per week
• Duration of complaint \>=3 months
• Associated with complaint of daytime impairment
• Reports spending at least 7 hours in bed per night
• History of intermittent \[taking zolpidem at least 3 or 4 nights per week\], or frequent use (at least 5 nights per week) of ZOL-IR or ZOL-ER, for at least 1 month
• Confirmation of intermittent or frequent use of zolpidem (based on review of drug use data). Intermittent use is defined as taking zolpidem at least 3 but fewer than 5 nights per week, for at least 2 weeks each of the 3-week Screening Period. Frequent use is defined as taking zolpidem at least 5 nights per week, during, at minimum, the last 2 weeks of the 3-week Screening Period
• Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
• Willing not to start another pharmacologic treatment for the management of insomnia during the participant's participation in the study

You may not qualify if:

• Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive serum pregnancy test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
• Females of childbearing potential who:
• Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
• total abstinence (if it is their preferred and usual lifestyle)
• an intrauterine device or intrauterine hormone-releasing system (IUS)
• a contraceptive implant
• an oral contraceptive (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)
• have a vasectomized partner with confirmed azoospermia
• Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
• Any history of moderate or severe obstructive sleep apnea (OSA)
• Current evidence of a clinically significant, active respiratory disorder other than mild OSA. This includes bronchiectasis, emphysema, asthma, chronic obstructive pulmonary disease or any other pulmonary disorder identified by review of medical history or physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments
• STOP-Bang score \>=5 (participants previously diagnosed with mild OSA are not excluded)
• International Restless Legs Scale (IRLS) score \>=16
• Habitually naps during the day more than 3 times per week
• Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (17)

PACT

Glendale, Arizona, 85306, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS

San Diego, California, 92103, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705, United States

Location

Fleming Island Center For Clinical Research - ERN-PPDS

Fleming Island, Florida, 32003, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions Inc

Orlando, Florida, 32801, United States

Location

NeuroTrials Research Inc. - BTC - PPDS

Atlanta, Georgia, 30342, United States

Location

SleepCare Research Institute Inc

Stockbridge, Georgia, 30281, United States

Location

Chicago Research Center Inc - ClinEdge - PPDS

Chicago, Illinois, 60634, United States

Location

Centennial Medical Group - Elkridge - Rx Trials

Elkridge, Maryland, 21075, United States

Location

Albuquerque Neurosciences Inc

Albuquerque, New Mexico, 87109, United States

Location

Clinilabs Drug Development Corporation

New York, New York, 10019, United States

Location

CTI Clinical Research Center - ClinEdge - PPDS

Cincinnati, Ohio, 45212, United States

Location

Clinical Neuroscience Solutions Inc

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

leukocyte endogenous mediator; lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_medinfo@eisai.com

+1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: July 15, 2019
• Primary Completion: March 17, 2020
• Study Completion: June 26, 2020
• Last Updated: April 12, 2021
• Results First Posted: April 12, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (17)