Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Model scores of the 29,894 trials active now.

Model score 15% 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 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 2016-10-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Phase: 3 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: greater thanprogressiveonsettimesuln
  Phrases that lowered it: participantparticipantssafetytermevaluate
• Blinding: quadruple (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 6 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: not given (lowers risk) · Who can join
• Sponsor's past trials: 5 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history

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
• 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
• Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome NCT02834793 · started 2016 · scored riskier than 26% of active trials terminated
• Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures NCT01648101 · started 2012 · scored riskier than 63% of active trials terminated
• 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

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.