Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients
Model scores of the 29,894 trials active now.
Model score 19% 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 14% of the time (453 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 2015-10-31, after 2014-07-30 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 2015-10-31. 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: tolerabilitythe safetypharmacokinetics andadvancedparkinson disease
Phrases that lowered it: oral administrationeffectpharmacokineticdrugplasma -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 35 (lowers risk) · Who can join
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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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: 75 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (raises risk) · Design
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Drug's FAERS reports with a death: 11.8% (lowers risk) · Drug's FDA history
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Keywords listed: 0 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 79.9% (lowers risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Allocation: non randomized (raises risk) · Design
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Number of arms: 2 (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
- 2
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 35 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 872 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 215 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carbidopa 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 Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients NCT01229332 · started 2011 · scored riskier than 12% of active trials completed
- A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients NCT02096601 · started 2014 · scored riskier than 12% of active trials completed
- Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease NCT00335153 · started 2008 · scored riskier than 13% of active trials completed
- A Safety, Tolerability and Levodopa Pharmacokinetics Study of Repeated ND0612 in Parkinson's Disease Patients NCT01883505 · started 2014 · scored riskier than 50% of active trials completed
- A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease NCT02271503 · started 2015 · scored riskier than 8% 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.