Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

Model scores of the 29,894 trials active now.

Model score 23% 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 13% of the time (1,304 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-04-17. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: alzheimerdementiaaddisorderrandomization
  Phrases that lowered it: efficacy andand safetypressureperiodsafety of
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 10.0% (raises risk) · Sponsor's track record
• Minimum age: 60 (raises risk) · Who can join
• Design: parallel (raises risk) · Design
• Phase: 2 (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Number of arms: 5 (lowers risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 21 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Maximum age: 90 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports before start: 1 (lowers risk) · Drug's FDA history
• Keywords listed: 3 (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.

• Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) NCT02783729 · started 2016 · scored riskier than 68% of active trials completed
• Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) NCT02750306 · started 2016 · scored riskier than 88% of active trials completed
• Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older NCT03008447 · started 2016 · scored riskier than 3% of active trials completed
• Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea NCT03471871 · started 2018 · scored riskier than 5% of active trials completed
• Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) NCT06843187 · started 2024 · scored riskier than 55% of active trials terminated

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.