A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorder
Bibliographic record
Abstract
INTRODUCTION: This study evaluated the efficacy and safety of lemborexant (LEM), a dual orexin-receptor antagonist, in participants with insomnia disorder in China. METHODS: E2006-J086-311 (Study 311; NCT04549168), a 1-month, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group study, enrolled adults (≥18 years) with insomnia disorder in China. Pairs of polysomnograms were conducted during a 7-day PBO run-in period (baseline), after the first 2 doses of LEM 10 mg (LEM10) or PBO, and after the last 2 doses at the end of 1 month of treatment. Objective sleep parameter assessments included latency to persistent sleep (LPS; primary endpoint) and secondary endpoints of sleep efficiency, wake after sleep onset (WASO), and total sleep time (TST; exploratory endpoint). Safety data were collected. RESULTS: Among 194 participants randomized (PBO, n = 100; LEM10, n = 94), the median age was approximately 42 years; most participants were female (PBO: 74.0 %; LEM10: 61.3 %). Following 1 month of treatment, mean (standard deviation [SD]) decreases from baseline in LPS were larger (improved) for the LEM10 treatment group (-39.47 min [46.147 min]) versus PBO (-21.71 min [42.809 min]; post hoc Box-Cox transformation, p = 0.0096). LEM10 demonstrated larger and statistically significant increases from baseline (improvements) in sleep efficiency (p < 0.0001) and TST (p < 0.0001) and significant decreases from baseline (improvement) in WASO (p = 0.0002) versus PBO and was well-tolerated. No new safety signals with LEM were observed in the current study compared with the known safety profile. CONCLUSIONS: LEM may be an important potential treatment option for patients with insomnia in China. TRIAL REGISTRATION: ClinicalTrials.gov identifier (first submitted on 09-09-2020): NCT04549168; Study protocol and statistical analysis plan may be accessed at: https://clinicaltrials.gov/study/NCT04549168.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".