PDE Inhibitors in DMD Study (Acute Dosing Study)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (201 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.
How it ended
Completed.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heart failurecardiacventricularischemiastandard
Phrases that lowered it: clinicalstudy toamlodipinedosingrenal impairment -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 67.3% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Minimum age: 7 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 15.2% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 15 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 6041 (lowers risk) · Drug's FDA history
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Number of arms: not given (lowers risk) · Design
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Has a data monitoring committee: No (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 trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- not given (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 7 (typical: 18)
- Maximum age
- 15 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 27 (typical: 32)
- Sponsor's past termination rate
- 14.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 25528 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6041 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, musculoskeletal
- Drugs matched to FDA substances
- sildenafil, tadalafil
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents NCT02964377 · started 2016 · scored riskier than 56% of active trials completed
- Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients NCT01396239 · started 2011 · scored riskier than 89% of active trials completed
- Twice Weekly Steroids and Exercise as Therapy for DMD NCT04322357 · started 2020 · scored riskier than 80% of active trials completed
- Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy NCT01168908 · started 2010 · scored riskier than 97% of active trials terminated
- Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD NCT04632940 · started 2021 · scored riskier than 75% 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.