Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-02-28, after 2020-10-01 start.
Reason given by the sponsor: “business”
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 2023-02-28. 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) (lowers risk) · Wording
Phrases that raised it: multiple sclerosistherapydiseasemsstable
Phrases that lowered it: malethe trialscreeningvisitfemale -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 9.3% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 3.6% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
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Sponsor's past trials: 108 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 90.0% (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 108 (typical: 32)
- Sponsor's past termination rate
- 9.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 361 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 96 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, immunology, musculoskeletal
- Drugs matched to FDA substances
- nabiximols
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
- Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis NCT04657666 · started 2020 · scored riskier than 16% of active trials completed
- Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis NCT04984278 · started 2021 · scored riskier than 26% of active trials terminated
- BX-1 in Spasticity Due to Multiple Sclerosis NCT03756974 · started 2019 · scored riskier than 49% of active trials completed
- Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis NCT01743651 · started 2012 · scored riskier than 51% of active trials completed
- A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS NCT03319732 · started 2018 · scored riskier than 55% 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.