Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (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 and sponsor type, started 2008–2016) ended terminated 21% of the time (1,462 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 on 2014-04-30, after 2013-07-31 start.
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; it actually ended on 2014-04-30. 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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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: placebosafety tolerabilitymultipledosestolerability pharmacokinetics
Phrases that lowered it: pharmacokineticsvolunteersefficacybodydisorder -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 9 (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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Maximum age: 50 (raises risk) · Who can join
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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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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (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
- 9 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- Evaluation of Immediate-Release Viloxazine in Adults With ADHD NCT01107496 · started 2010 · scored riskier than 10% of active trials completed
- Effectiveness of Lobeline in Treating Symptoms of ADHD in Adult Patients NCT00664703 · started 2008 · scored riskier than 11% of active trials completed
- Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD) NCT02604407 · started 2015 · scored riskier than 30% of active trials completed
- Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD) NCT02808104 · started 2016 · scored riskier than 43% of active trials completed
- Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) NCT00904670 · started 2009 · scored riskier than 12% 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.