Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Model scores of the 29,894 trials active now.

Model score 14% 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 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 2011-12-31. 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 termseizuresextensionterm safetyprotocol
  Phrases that lowered it: patientsefficacyclinical trialthe previousevaluate
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 3.8% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 61 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 173 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 92.4% (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 9189 (lowers risk) · Drug's FDA history
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 3166 (lowers risk) · Drug's FDA history
• 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.

• A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures NCT01463306 · started 2012 · scored riskier than 16% of active trials completed
• A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures. NCT01747915 · started 2013 · scored riskier than 30% of active trials completed
• A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years NCT01389596 · started 2011 · scored riskier than 24% of active trials completed
• A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. NCT02072824 · started 2014 · scored riskier than 33% of active trials completed
• Once-A-Day Pregabalin For Partial Seizures NCT01262677 · started 2011 · scored riskier than 34% 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.