Dexpramipexole SAD/MAD Study

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (544 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 2012-01-31. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: heartqtcqtfailureplacebo controlled
  Phrases that lowered it: healthyvolunteerspharmacokineticssinglescreening
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 10 (lowers risk) · Design
• Blinding: double (raises risk) · Design
• Maximum age: 55 (lowers risk) · Who can join
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 3 (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.

• Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate) NCT01511029 · started 2012 · scored riskier than 1% of active trials completed
• Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects NCT01607034 · started 2012 · scored riskier than 0% of active trials completed
• A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers NCT03164109 · started 2017 · scored riskier than 1% of active trials completed
• Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions NCT02956525 · started 2018 · scored riskier than 1% of active trials completed
• A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA) NCT02529787 · started 2013 · scored riskier than 0% 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.