A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2012-05-31. 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) (lowers risk) · Wording Phrases that raised it: placebocontrolleddouble blindsurgicaldisease
  Phrases that lowered it: mass indexbody massevaluate theto evaluatesafety
• Design: crossover (lowers risk) · Design
• Sponsor's past termination rate: 2.4% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Phase: 2 (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: triple (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 42 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 2 (raises risk) · Design
• Maximum age: 65 (raises risk) · Who can join
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 10 (lowers risk) · Sponsor's track record

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.

• A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy NCT01681121 · started 2012 · scored riskier than 10% of active trials completed
• Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy NCT01067222 · started 2009 · scored riskier than 26% of active trials completed
• A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy NCT05059223 · started 2021 · scored riskier than 11% of active trials completed
• Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy NCT02720744 · started 2016 · scored riskier than 66% of active trials completed
• Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy NCT02348593 · started 2015 · scored riskier than 13% 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.