Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Model scores of the 29,894 trials active now.
Model score 20% 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 14% of the time (201 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-06-01, after 2018-11-01 start.
Reason given by the sponsor: “enrollment”
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 2019-06-01. 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: parkinson diseasebraincontrolledivparticipants
Phrases that lowered it: screening18 tomonths priordays precedingthe investigator -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 561 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 17.9% (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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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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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 154 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Keywords listed: 5 (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 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 95 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 561 (typical: 32)
- Sponsor's past termination rate
- 14.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 154 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 38263 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6027 (typical: 412.5)
- Drug's FAERS reports marked serious
- 17.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- botulinum toxin type a, 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
- OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females NCT02116361 · started 2014 · scored riskier than 28% of active trials completed
- The Treatment of Depression With Botulinum Type A Toxin NCT01392963 · started 2011 · scored riskier than 32% of active trials completed
- Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients NCT02453386 · started 2015 · scored riskier than 37% of active trials terminated
- Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. NCT03051607 · started 2017 · scored riskier than 21% of active trials terminated
- A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease NCT00880620 · started 2009 · scored riskier than 19% 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.