Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects

NCT00616655 on ClinicalTrials.gov Phase 2 Sumitomo Pharma America, Inc. (industry) Started 2008-01-31 Completed

Riskier than 9% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 16% of the time (269 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 2008-12-31, after 2008-01-31 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 2008-12-31. 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) (lowers risk) · Wording Phrases that raised it: seizurestherapyto determinestablediagnosis
Phrases that lowered it: subjectssubjectbodybetween 18and safety
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 7.3% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 0.7% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 50 (lowers risk) · Who can join
Sponsor's past trials: 37 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record

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: 1

Who can join

Minimum age: 18
Maximum age: 50 (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: 37 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 9 (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: 9699 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2928 (typical: 412.5)
Drug's FAERS reports marked serious: 7.3% (typical: 85.6%)
Drug's FAERS reports with a death: 0.7% (typical: 15.9%)

Disease area and drugs

Disease areas: psychiatry
Drugs matched to FDA substances: eszopiclone

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 Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder NCT05729373 · started 2023 · scored riskier than 31% of active trials completed
A Dose-Response Safety Study of ENX-102 in Patients With GAD NCT06653296 · started 2024 · scored riskier than 16% of active trials completed
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325 NCT00807937 · started 2008 · scored riskier than 81% of active trials completed
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1) NCT00658008 · started 2008 · scored riskier than 14% of active trials terminated
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2) NCT00658372 · started 2008 · scored riskier than 13% 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.