Open-Label Safety Study of ADS-5102 in PD Patients With LID
Model scores of the 29,894 trials active now.
Model score 12% 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 15% of the time (734 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 2018-02-28, after 2014-07-31 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 2018-02-28. 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: screeningdiseaseor plannedwithin yearscancer
Phrases that lowered it: completeddailyefficacylabeltrial -
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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Minimum age: 30 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
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Maximum age: 85 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 79.3% (lowers risk) · Drug's FDA history
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Keywords listed: 4 (lowers 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
- 3 (typical: 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 30 (typical: 18)
- Maximum age
- 85 (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
- 2 (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3464 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 653 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- amantadine
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
- Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) NCT01397422 · started 2011 · scored riskier than 37% of active trials completed
- ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) NCT02136914 · started 2014 · scored riskier than 24% of active trials completed
- Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia NCT02274766 · started 2014 · scored riskier than 25% of active trials completed
- Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. NCT02153645 · started 2014 · scored riskier than 16% of active trials terminated
- Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID NCT02153632 · started 2014 · scored riskier than 16% of active trials terminated
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.