Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects

Model scores of the 29,894 trials active now.

Model score 13% 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 16% of the time (269 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 2015-01-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subject hassubject isdsmhas historyscore of
  Phrases that lowered it: evaluate theto evaluatesubjectssingleadministration
• 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
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Blinding: triple (raises risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Keywords listed: 3 (lowers risk) · Design
• Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Maximum age: 17 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Responsible party: sponsor (lowers 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 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity ) NCT02059642 · started 2014 · scored riskier than 19% of active trials completed
• Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder NCT01685281 · started 2013 · scored riskier than 22% of active trials completed
• The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD NCT02477748 · started 2015 · scored riskier than 8% of active trials terminated
• A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome NCT02126995 · started 2014 · scored riskier than 87% of active trials completed
• Evaluation of Immediate-Release Viloxazine in Adults With ADHD NCT01107496 · started 2010 · scored riskier than 10% 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.