Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

NCT04164758 on ClinicalTrials.gov Phase 2 ACADIA Pharmaceuticals Inc. (industry) Started 2019-10-23 Terminated

Riskier than 64% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 4% 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 2020-09-25, after 2019-10-23 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 2020-09-25. 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) (raises risk) · Wording Phrases that raised it: parkinson diseasethe subjectsubjects within subjectssubject is
Phrases that lowered it: evaluatestudy tofemalehealthmale
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports before start: 131399 (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 14.4% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 50 (raises risk) · Who can join
Sponsor's past trials: 14 (lowers risk) · Sponsor's track record
Maximum age: 85 (raises risk) · Who can join
Drug's FAERS reports marked serious: 71.4% (lowers risk) · Drug's FDA history
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: 2
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 50 (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: 14 (typical: 32)
Sponsor's past termination rate: 7.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 5 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 131399 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16103 (typical: 412.5)
Drug's FAERS reports marked serious: 71.4% (typical: 85.6%)
Drug's FAERS reports with a death: 14.4% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: pimavanserin, quetiapine

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

A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis NCT06068465 · started 2024 · scored riskier than 29% of active trials completed
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis NCT01174004 · started 2010 · scored riskier than 31% of active trials completed
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 · started 2018 · scored riskier than 10% of active trials completed
A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease NCT03575052 · started 2018 · scored riskier than 83% of active trials completed
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression NCT03482882 · started 2018 · scored riskier than 63% 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.