A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2015-04-30, after 2015-04-30 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 2015-04-30. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: greatersubjects withfailurediseasegi
Phrases that lowered it: healthyabusealcoholjudgedmass index -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: not given (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Minimum age: 40 (lowers risk) · Who can join
-
Design: single group (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Blinding: none (lowers risk) · Design
-
Drug's FAERS reports marked serious: 75.7% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 17679 (raises risk) · Drug's FDA history
-
Number of arms: 1 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 6 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 17679 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2922 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carbidopa, carbidopa levodopa, levodopa
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
- A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects NCT02604914 · started 2015 · scored riskier than 1% of active trials completed
- Dose-finding Pharmacokinetic Study in Healthy Males NCT03055936 · started 2017 · scored riskier than 1% of active trials completed
- Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa NCT02169479 · started 2008 · scored riskier than 0% of active trials completed
- Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide NCT01533116 · started 2009 · scored riskier than 1% of active trials completed
- Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide NCT02169895 · started 2008 · scored riskier than 0% 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.