A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% 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 (95 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.
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. 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: melanomastagethe patientlungregistration
Phrases that lowered it: the effectpharmacokineticsvolunteerseffect ofinteraction -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Phase: 1/2 (raises risk) · Design
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Minimum age: 30 (lowers risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 10.5% (lowers risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 71.7% (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 3713 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 713 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- levodopa, safinamide
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
- Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects NCT01113320 · started 2010 · scored riskier than 28% of active trials completed
- A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging NCT01264861 · started 2011 · scored riskier than 35% of active trials terminated
- A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa NCT03881371 · started 2019 · scored riskier than 31% of active trials completed
- Safinamide for Multiple System Atrophy (MSA) NCT03753763 · started 2019 · scored riskier than 58% of active trials completed
- A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease NCT01211587 · started 2010 · 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.