Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (276 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 2020-04-30. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Drug's FAERS reports marked serious: 55.6% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Maximum age: 100 (lowers risk) · Who can join
• Design: parallel (raises risk) · Design
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: or equalequal totherapymgwomen
  Phrases that lowered it: nasaland safetyefficacy andsafety ofpositive
• Primary purpose: treatment (raises risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Blinding: double (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Disease area, respiratory: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Number of arms: 2 (raises 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.

• A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA NCT05223166 · started 2022 · scored riskier than 9% of active trials completed
• Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) NCT01789398 · started 2012 · scored riskier than 31% of active trials completed
• Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant) NCT01399606 · started 2011 · scored riskier than 42% of active trials completed
• A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia NCT05156047 · started 2022 · scored riskier than 37% of active trials completed
• A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) NCT06103825 · started 2023 · scored riskier than 14% 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.