Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 5% 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 2011-08-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: uncontrolledprimaryto assessassess thesubject has
  Phrases that lowered it: subjectsexaminationsafety ofscreeningvisit
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: 73.0% (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Minimum age: 16 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 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 Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy NCT01118962 · started 2010 · scored riskier than 69% of active trials completed
• eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam NCT01484977 · started 2011 · scored riskier than 29% of active trials completed
• Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures NCT00655551 · started 2008 · scored riskier than 34% of active trials completed
• A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures NCT01710657 · started 2012 · scored riskier than 19% of active trials completed
• A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications NCT02408523 · started 2015 · scored riskier than 77% 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.