Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 2% 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 (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-05-07, after 2015-02-09 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 2019-05-07. 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) (lowers risk) · Wording
Phrases that raised it: subjects withand neckhead andbrainthe subject
Phrases that lowered it: and safetyefficacy andinvestigatesafety ofthe efficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 10% (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 20.3% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 1.4% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Number of arms: 5 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Minimum age: 2 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 8 (lowers risk) · Sponsor's track record
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Maximum age: 17 (raises risk) · Who can join
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Blinding: double (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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 17 (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
- 40 (typical: 32)
- Sponsor's past termination rate
- 10% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 17918 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3213 (typical: 412.5)
- Drug's FAERS reports marked serious
- 20.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, psychiatry
- Drugs matched to FDA substances
- botulinum toxin type a, incobotulinumtoxina
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
- Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions NCT02091739 · started 2014 · scored riskier than 60% of active trials completed
- Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults NCT02610868 · started 2015 · scored riskier than 44% of active trials completed
- Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring NCT01515371 · started 2012 · scored riskier than 20% of active trials terminated
- Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy NCT03616067 · started 2022 · scored riskier than 21% of active trials terminated
- Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism NCT01653132 · started 2012 · scored riskier than 84% 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.