An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months

Model scores of the 29,894 trials active now.

Model score 7% 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 15% of the time (734 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 2011-05-31. 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) (lowers risk) · Wording Phrases that raised it: subject hasenrollmentdepressiveulndefined
  Phrases that lowered it: irritationpatchvital signsevaluate theto evaluate
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 65 (lowers risk) · Who can join
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• 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.

• The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine NCT00724815 · started 2009 · scored riskier than 9% of active trials completed
• Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period NCT00723983 · started 2008 · scored riskier than 4% of active trials completed
• An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months NCT00792103 · started 2009 · scored riskier than 17% of active trials completed
• Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults NCT01381796 · started 2009 · scored riskier than 0% of active trials completed
• Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers NCT00720018 · started 2008 · scored riskier than 1% 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.