Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (544 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-04-21, after 2014-12-13 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-04-21. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 22.3% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: greateror equalequal toplacebo controlleddouble
Phrases that lowered it: crossoverscreeningparticipantway28 -
Maximum age: 99 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Keywords listed: 4 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 188 (typical: 32)
- Sponsor's past termination rate
- 10.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 24 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 864 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 105 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry
- Drugs matched to FDA substances
- flurazepam, lemborexant
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder NCT05594589 · started 2022 · scored riskier than 20% of active trials completed
- A Study of Lemborexant in Chinese Participants With Insomnia Disorder NCT04549168 · started 2020 · scored riskier than 18% of active trials completed
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia NCT01995838 · started 2013 · scored riskier than 56% of active trials completed
- Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia NCT02671760 · started 2016 · scored riskier than 12% of active trials completed
- SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. NCT03331042 · started 2017 · scored riskier than 6% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.