Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-11-30, after 2016-05-02 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 2017-11-30. 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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Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: stroketherapyto determinescoremini mental
Phrases that lowered it: the aimaim ofinjectiontrialimpairment -
Drug's FAERS reports marked serious: 17.3% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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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: 72 (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports with a death: 1.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 5054 (raises risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 108 (typical: 32)
- Sponsor's past termination rate
- 2.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 72 (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
- 25911 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5054 (typical: 412.5)
- Drug's FAERS reports marked serious
- 17.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, musculoskeletal
- Drugs matched to FDA substances
- botulinum toxin type a
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
- Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections NCT04502264 · started 2020 · scored riskier than 23% of active trials completed
- Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A NCT03302871 · started 2016 · scored riskier than 12% of active trials completed
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke NCT01392300 · started 2011 · scored riskier than 15% of active trials completed
- Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity NCT01915459 · started 2013 · scored riskier than 5% of active trials completed
- Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength During Locomotion in Chronic Hemiparetic Patients NCT01821573 · started 2013 · scored riskier than 57% 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.