Phase 1
Completed N=69
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
Source: ClinicalTrials.gov NCT02350309 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 — 18.25; 18.28; 18.25; -3.43 minutes — p=0.0262
Summary
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3 |
18.25; 18.28; 18.25; -3.43; -4.56; -6.95 | 0.0262 sig |
| SECONDARY Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment |
3; 11; 20; 36 | 0.0215 sig |
| SECONDARY Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo |
9; 20; 35 | — |
| SECONDARY Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo |
4; 13; 25 | — |
| SECONDARY Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4 |
18.25; -9.49 | — |
| SECONDARY Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT |
2.285; 6.423; 1.246; 2.582; 3.236; 5.306 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) That Led to Death and Study Drug Discontinuation |
2; 5; 8; 5; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Laboratory Values |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters |
0; 0; 0; 0 | — |
| SECONDARY Relationship Between PK Concentrations of Lemborexant and Sleepiness as Measured by M-MSLT |
-0.2746 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age 18 or older, at the time of informed consent.
- Meets the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia Disorder, as follows:
- Complains of dissatisfaction with nighttime sleep despite adequate opportunity for sleep, with complaint being one or more of the following: difficulty getting to sleep, difficulty staying asleep, or awakening earlier in the morning than desired.
- Frequency of complaint greater than or equal to 3 times per week.
- Duration of complaint greater than or equal to 3 months.
- Associated with complaint of daytime impairment.
- Insomnia Severity Index score greater than or equal to 15 at Screening.
- Regular time in bed between 7 and 9 hours as reported at Screening.
- Regular bedtime, defined as the time the participant attempts to fall asleep, between 21:00 and 24:00 and regular wake time between 05:00 and 09:00 as reported at Screening.
- Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed for 7 nights during Screening, such that participant Sleep Onset Latency (sSOL) greater than or equal to 30 minutes on at least 3 nights and subjective Wake After Sleep Onset (sWASO) greater than or equal to 60 minutes on at least 3 nights.
Exclusion Criteria
- Excessive morning sleepiness at Baseline as determined by average SOL at Baseline less than 10 minutes.
- Females must not be lactating or pregnant at Screening or Baseline (documented by a negative beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG). (Note: A negative urine pregnancy test is required at check-in before each dose of study drug and flurazepam).
- If females of childbearing potential:
- Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
- Are currently abstinent, and do not agree to use a double barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
- Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and do not agree to use the same contraceptive during the study or 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).
- A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia.
- Reports experiencing within the past year confusional arousals, symptoms of REM Behavior Disorder, or sleep-related violent behavior on Munich Parasomnia Scale (MUPS), or a history of aberrant nocturnal behaviors including sleep-driving or sleep-eating.
- Habitually naps more than 3 times per week.
- History of drug or alcohol dependency or abuse within approximately the last 2 years.
- Has a positive drug screen at Screening.
- A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated ECG at
Data sourced from ClinicalTrials.gov (NCT02350309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.