Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Model scores of the 29,894 trials active now.
Model score 10% 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 2019-08-31, after 2016-01-31 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 2019-08-31. 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.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 49.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 4.0% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: long termterm safetythe longreceivingextension
Phrases that lowered it: evaluate theto evaluateefficacyand safetyadhd -
Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 18 (raises risk) · Who can join
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises 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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 18 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 28771 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6250 (typical: 412.5)
- Drug's FAERS reports marked serious
- 49.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- methylphenidate
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
- Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD NCT02450890 · started 2015 · scored riskier than 8% of active trials completed
- Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder NCT01338818 · started 2011 · scored riskier than 67% of active trials completed
- A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder NCT00714688 · started 2008 · scored riskier than 22% of active trials completed
- Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4) NCT02691182 · started 2016 · scored riskier than 28% of active trials terminated
- Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD) NCT01259492 · started 2010 · scored riskier than 27% 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.