Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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 2011-07-31, after 2011-02-28 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 2011-07-31. 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: subjectpriorriskbrainparkinson disease
Phrases that lowered it: single dosemaleevaluate theto evaluatehealth -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Primary purpose: prevention (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 6.5% (lowers risk) · Sponsor's track record
-
Minimum age: 30 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 10.2% (lowers risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
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
-
Maximum age: not given (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 71.0% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 31 (lowers 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
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (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
- 31 (typical: 32)
- Sponsor's past termination rate
- 6.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 4481 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 797 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carbidopa
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
- Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations NCT01766258 · started 2011 · scored riskier than 15% of active trials completed
- Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon NCT01568073 · started 2011 · scored riskier than 42% of active trials completed
- Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients NCT01568047 · started 2010 · scored riskier than 14% of active trials completed
- PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding NCT00562198 · started 2008 · scored riskier than 20% of active trials terminated
- A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 NCT01130493 · started 2010 · scored riskier than 15% 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.