Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis
Model scores of the 29,894 trials active now.
Model score 14% 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 17% of the time (276 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-07-28, after 2019-01-24 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 2022-07-28. 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) (raises risk) · Wording
Phrases that raised it: multiple sclerosis18 andmsrelapsingage
Phrases that lowered it: patientsweeks beforelifetreatmentterm -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 18.2% (lowers risk) · Drug's FDA history
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Responsible party: sponsor investigator (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 1.6% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Design: single group (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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
- No (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 38705 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6242 (typical: 412.5)
- Drug's FAERS reports marked serious
- 18.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology
- 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
- The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor NCT01018485 · started 2008 · scored riskier than 50% of active trials completed
- Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy NCT01905683 · started 2013 · scored riskier than 13% of active trials completed
- Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea NCT01551940 · started 2012 · scored riskier than 69% of active trials completed
- Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS NCT01911377 · started 2013 · scored riskier than 66% of active trials terminated
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke NCT01464307 · started 2011 · scored riskier than 16% 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.