A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Model scores of the 29,894 trials active now.
Model score 14% 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 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-03-15, after 2017-07-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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; it actually ended on 2019-03-15. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subject hassubject isthe subjectsubjects withrandomization
Phrases that lowered it: and safetyefficacy andtrialasthmachildren -
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Minimum age: 6 (lowers risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Sponsor's past trials: 113 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 12 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 113 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- none matched
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
- A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting. NCT02734693 · started 2016 · scored riskier than 20% of active trials completed
- Dasotraline Pediatric ADHD Study NCT02428088 · started 2015 · scored riskier than 12% of active trials completed
- A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD NCT06359899 · started 2024 · scored riskier than 27% of active trials completed
- Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD NCT06431256 · started 2024 · scored riskier than 17% of active trials terminated
- Dasotraline Adult ADHD Study NCT02276209 · started 2014 · scored riskier than 8% 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.