Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 16% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (376 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 2016-10-12, after 2008-11-17 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 2016-10-12. 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: painsubjectsplaceboor equalgreater
Phrases that lowered it: mildto moderateparticipantsintendedexamination -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 5.0% (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor's past trials: 259 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: government (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 93.5% (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 235 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: 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
- government (typical: academic or other)
- Sponsor's past trials
- 259 (typical: 32)
- Sponsor's past termination rate
- 5.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 235 (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
- 964 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 501 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- 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
- Botulinum Toxin for Pelvic Pain in Women With Endometriosis NCT01553201 · started 2014 · scored riskier than 35% 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
- Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain NCT01967524 · started 2013 · scored riskier than 63% of active trials completed
- Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain NCT05096494 · started 2022 · scored riskier than 21% 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
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.