Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)
Model scores of the 29,894 trials active now.
Model score 15% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-02-17, after 2020-07-30 start.
Reason given by the sponsor: “enrollment”
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 2022-02-17. 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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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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Phase: 2 (raises risk) · Design
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Minimum age: 30 (lowers risk) · Who can join
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Disease area, neurology: Yes (raises risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: parkinson diseasesubjects mustconstipationable tosubject
Phrases that lowered it: evaluate theopen labelto evaluaterandomizedstudy will -
Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
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Keywords listed: 0 (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
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 18)
- Maximum age
- 90 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- none matched
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
- Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation NCT03047629 · started 2017 · scored riskier than 53% of active trials completed
- Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) NCT03781791 · started 2018 · scored riskier than 46% of active trials completed
- A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation NCT01955616 · started 2013 · scored riskier than 47% of active trials terminated
- Targin for Non-cancer Pain NCT01918098 · started 2013 · scored riskier than 16% of active trials completed
- NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa NCT05083260 · started 2022 · scored riskier than 26% 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.