A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

Model scores of the 29,894 trials active now.

Model score 27% for any early termination, 10% 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 2013-08-31. 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) (raises risk) · Wording Phrases that raised it: birthgrapefruitgreater thanseizuressubject
  Phrases that lowered it: patientscompletedtreatmentbenefittherapy
• Sponsor's past termination rate: 33.3% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Number of arms: 1 (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Collaborators: 0 (raises risk) · Design
• Sponsor's past trials: 3 (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 Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures NCT02519439 · started 2015 · scored riskier than 45% of active trials terminated
• Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension NCT01963208 · started 2013 · scored riskier than 40% of active trials completed
• Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) NCT04285346 · started 2020 · scored riskier than 86% of active trials completed
• Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies NCT02358538 · started 2015 · scored riskier than 32% of active trials completed
• Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy NCT05323734 · started 2022 · scored riskier than 48% 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.