A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Model scores of the 29,894 trials active now.

Model score 14% 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 15% of the time (734 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 2023-09-08. 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: disorderstablediagnosispriorscale
  Phrases that lowered it: participantparticipantsevaluate theto evaluatepressure
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 44.2% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 0.2% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Blinding: triple (raises risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (lowers risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 3 (raises 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.

• Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1 NCT04886518 · started 2021 · scored riskier than 38% of active trials completed
• A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension NCT04257929 · started 2020 · scored riskier than 40% of active trials completed
• Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA NCT02739568 · started 2016 · scored riskier than 24% 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
• 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.