A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

Model scores of the 29,894 trials active now.

Model score 20% 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 19% of the time (731 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 2024-12-17. 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.

• Sponsor's past termination rate: 16.9% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellmutationother protocolkeymay apply
  Phrases that lowered it: pharmacokineticsmultiplescreeningclinically significantrespiratory
• Has a data monitoring committee: Yes (raises risk) · Design
• Primary purpose: prevention (lowers risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 0 (lowers risk) · Who can join
• Sponsor's past trials: 178 (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Maximum age: 0.12 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record

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 Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA) NCT01839656 · started 2013 · scored riskier than 90% of active trials completed
• An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy NCT01703988 · started 2012 · scored riskier than 91% of active trials completed
• An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) NCT01494701 · started 2011 · scored riskier than 81% of active trials completed
• A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies NCT02594124 · started 2015 · scored riskier than 90% of active trials completed
• An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246) NCT02052791 · started 2014 · scored riskier than 39% 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.