Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 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 2013-02-28. 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: colitispriorsclerosisradiationactive
  Phrases that lowered it: allergicparticipantsbleedingmultiplehistory
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, neurology: Yes (raises risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 60 (lowers risk) · Who can join
• Responsible party: principal investigator (lowers risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Sponsor's past trials: 7 (raises risk) · Sponsor's track record
• Keywords listed: 7 (lowers risk) · Design
• Collaborators: 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.

• Safety of Polyphenon E in Multiple Sclerosis Pilot Study NCT00836719 · started 2009 · scored riskier than 91% of active trials completed
• Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck NCT01116336 · started 2010 · scored riskier than 96% of active trials completed
• Sunphenon in Progressive Forms of Multiple Sclerosis NCT00799890 · started 2009 · scored riskier than 64% of active trials completed
• Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis NCT06083753 · started 2023 · scored riskier than 91% of active trials completed
• Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) NCT02936037 · started 2016 · scored riskier than 32% of active trials terminated

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.