A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

NCT03922711 on ClinicalTrials.gov Phase 2 Prilenia (industry) Started 2019-05-22 Terminated

Riskier than 52% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 5% 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 2020-07-22, after 2019-05-22 start.

Reason given by the sponsor: “other”

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 2020-07-22. 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

Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Minimum age: 30 (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: stablepriorparkinson diseaseto screeningplacebo
Phrases that lowered it: the efficacyand safetyefficacy andsafety ofparallel
Blinding: quadruple (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Disease area, neurology: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Maximum age: 85 (lowers risk) · Who can join
Drug's FAERS reports with a death: 0% (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: 2
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (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: 4 (typical: 32)
Sponsor's past termination rate: 25% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 2 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: pridopidine

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
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease NCT05766813 · started 2023 · scored riskier than 24% of active trials completed
Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia NCT03368170 · started 2018 · scored riskier than 39% of active trials completed
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. NCT00903838 · started 2009 · scored riskier than 13% of active trials terminated
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia NCT05297201 · started 2021 · 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.