Ambroxol in Disease Modification in Parkinson Disease
Model scores of the 29,894 trials active now.
Model score 11% 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 14% of the time (453 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-31, after 2016-12-31 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 2018-05-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: failurecoronarydiseaseparkinsonheart
Phrases that lowered it: participantsparticipantdaylabelevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Primary purpose: prevention (lowers risk) · Design
-
Minimum age: 40 (lowers risk) · Who can join
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Maximum age: 80 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 97.0% (raises risk) · Drug's FDA history
-
Collaborators: 1 (raises risk) · Design
-
Sponsor's past trials: 63 (lowers risk) · Sponsor's track record
-
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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- prevention (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
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 63 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 50 (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
- 1630 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 413 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- ambroxol
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
- Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes NCT05979415 · started 2023 · scored riskier than 12% of active trials terminated
- Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease NCT02542696 · started 2015 · scored riskier than 26% of active trials completed
- The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease NCT00623324 · started 2008 · scored riskier than 42% of active trials completed
- A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease NCT04685265 · started 2020 · scored riskier than 9% of active trials completed
- A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) NCT01155466 · started 2010 · scored riskier than 60% 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.