Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 7% 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 2020-10-13. 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: subjectsgreater thanor equalequal tosubject
  Phrases that lowered it: administrationproducttimeincludingsafety of
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 31 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 22.2% (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 18 (raises risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: 92.5% (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 0.5 (lowers risk) · Who can join
• Sponsor's past trials: 235 (lowers risk) · Sponsor's track record
• Collaborators: 1 (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.

• Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan NCT03336645 · started 2017 · scored riskier than 25% of active trials completed
• Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures NCT02535091 · started 2016 · scored riskier than 74% of active trials completed
• Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients NCT00918047 · started 2009 · scored riskier than 16% of active trials completed
• Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures NCT01284556 · started 2010 · scored riskier than 15% of active trials completed
• A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures. NCT01969851 · started 2014 · scored riskier than 49% 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.