A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)

NCT03391882 on ClinicalTrials.gov Phase 3 Sumitomo Pharma America, Inc. (industry) Started 2018-12-19 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 15% of the time (734 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2021-08-11, after 2018-12-19 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 2021-08-11. 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

Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 4.9% (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 48.0% (lowers risk) · Drug's FDA history
Disease area, neurology: Yes (raises risk) · Disease area
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: parkinson diseasecellbraincancermalignancy
Phrases that lowered it: screeningmaledayopen labelmg
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 7.5% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Maximum age: not given (lowers risk) · Who can join
Sponsor's past trials: 122 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor (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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: 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: 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: 122 (typical: 32)
Sponsor's past termination rate: 4.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 18 (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: 2467 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1122 (typical: 412.5)
Drug's FAERS reports marked serious: 48.0% (typical: 85.6%)
Drug's FAERS reports with a death: 7.5% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: apomorphine

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
A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis NCT02969369 · started 2016 · scored riskier than 50% of active trials completed
DNS-7801 vs. Placebo in Parkinson's Disease NCT03306329 · started 2017 · scored riskier than 90% of active trials terminated
A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF Episodes NCT03187301 · started 2017 · scored riskier than 22% of active trials completed
A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease NCT05435729 · started 2022 · scored riskier than 12% 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.