Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Model scores of the 29,894 trials active now.

Model score 35% 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 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 2024-03-11. 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: extensionlong termtolerabilitysafety andcompleted
  Phrases that lowered it: weeksvisitto evaluateparticipantsmedicine
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 47 (lowers risk) · Sponsor's track record
• Blinding: none (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Number of arms: 1 (raises risk) · Design
• Maximum age: 67 (lowers risk) · Who can join

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 to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures NCT05159908 · started 2021 · scored riskier than 47% of active trials completed
• Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep NCT05301894 · started 2022 · scored riskier than 82% of active trials terminated
• Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) NCT04873869 · started 2022 · scored riskier than 68% of active trials terminated
• Phase II BGG492 Capsule Extension for Partial Epilepsy NCT01338805 · started 2011 · scored riskier than 94% of active trials completed
• A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization NCT03250377 · started 2017 · scored riskier than 15% 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.