Botox for the Treatment of Chronic Exertional Compartment Syndrome
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (283 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-12-15, after 2019-10-08 start.
Reason given by the sponsor: “other”
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 2021-12-15. 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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Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chronicprior tounitspotentialdiagnosis of
Phrases that lowered it: participantsparticipantinjectionasthmatherapy -
Phase: 1/2 (raises risk) · Design
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Drug's FAERS reports marked serious: 37.5% (lowers risk) · Drug's FDA history
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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: 85 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 389 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 389 (typical: 32)
- Sponsor's past termination rate
- 13.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 85 (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
- 16 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7 (typical: 412.5)
- Drug's FAERS reports marked serious
- 37.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- onabotulinumtoxina
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
- Botulinum for Chronic Exertional Compartment Syndrome NCT03339921 · started 2018 · scored riskier than 21% of active trials terminated
- Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS) NCT04409600 · started 2020 · scored riskier than 63% of active trials completed
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity NCT04099667 · started 2019 · scored riskier than 23% of active trials terminated
- Injection With OnabotulinumtoxinA (Botox) for the Treatment of Chronic Pelvic Pain NCT02173405 · started 2014 · scored riskier than 57% of active trials completed
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity NCT04815967 · started 2021 · scored riskier than 23% of active trials terminated
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.