A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

NCT01929317 on ClinicalTrials.gov Phase 3 GlaxoSmithKline (industry) Started 2013-08-28 Terminated

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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

Terminated on 2015-06-09, after 2013-08-28 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 2015-06-09. 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

Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
Sponsor's past trials: 1820 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 7.4% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectparkinsonqtclong termdisease
Phrases that lowered it: the screeningpatients whoefficacydayscreening visit
Drug's FAERS reports marked serious: 69.3% (lowers risk) · Drug's FDA history

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: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 20 (typical: 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: 1820 (typical: 32)
Sponsor's past termination rate: 5.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 324 (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: 2058 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 454 (typical: 412.5)
Drug's FAERS reports marked serious: 69.3% (typical: 85.6%)
Drug's FAERS reports with a death: 7.4% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: ropinirole

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

Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease NCT00823836 · started 2009 · scored riskier than 10% of active trials completed
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa NCT01154166 · started 2010 · scored riskier than 21% of active trials completed
A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients NCT01628926 · started 2009 · scored riskier than 58% of active trials completed
Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) NCT04978597 · started 2021 · scored riskier than 34% of active trials completed
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon NCT01568073 · started 2011 · scored riskier than 42% 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.