Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Model scores of the 29,894 trials active now.

Model score 20% 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 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 2012-10-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: long termsubjects within subjectsextension studycompleted
  Phrases that lowered it: safetyinvestigatorstudy toigeto receive
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 6.3% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: 68.4% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 65 (raises risk) · Who can join
• Blinding: none (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Minimum age: 16 (raises 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.

• Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy NCT01118949 · started 2010 · scored riskier than 28% of active trials completed
• Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures NCT00530855 · started 2008 · scored riskier than 18% of active trials completed
• Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures NCT00655486 · started 2008 · scored riskier than 58% of active trials completed
• A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures NCT01964560 · started 2014 · scored riskier than 50% of active trials completed
• Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures NCT02408549 · started 2015 · scored riskier than 56% 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.