Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

Model scores of the 29,894 trials active now.

Model score 21% 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 in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-02-22. 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: sclerosislong termextensionterm safetythe long
  Phrases that lowered it: to investigateinvestigate thesafety ofpatient whonon
• Sponsor's past termination rate: 42.9% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Sponsor's past trials: 14 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Maximum age: 80 (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.

• Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis NCT05178810 · started 2021 · scored riskier than 51% of active trials completed
• A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) NCT00445172 · started 2008 · scored riskier than 40% of active trials completed
• Open Label Extension Study of AMX0035 in Patients With ALS NCT03488524 · started 2018 · scored riskier than 90% of active trials completed
• Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial NCT03836716 · started 2019 · scored riskier than 71% of active trials terminated
• Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS) NCT04288856 · started 2020 · scored riskier than 88% 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.